Treatment Safety and Efficacy Using Pro-ocular™ 1% for Chronic Ocular Graft-versus-host Disease (GvHD) Following Allogeneic Hematopoietic Stem Cell Transplantation.
| Registry | NCT03990051 |
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| Status | Completed |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 33 (Actual) |
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| Sponsor | Glia, LLC (Industry); collaborators: ORA, Inc. |
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| Conditions | Chronic Ocular Graft-versus-host Disease |
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| Interventions | Pro-ocular™ topical gel, Placebo topical gel (Drug) |
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| Dates | start 2019-10-17, primary completion 2021-10-31, completion 2021-11-19, first posted 2019-06-18, last updated 2025-05-06 |
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| Locations | 1 site in United States |
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-Summary
To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.
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+Detailed description
Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.
A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.
Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Pro-ocular™ | Experimental | Drug: Pro-ocular™ topical gel | Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime. |
| Placebo | Placebo comparator | Drug: Placebo topical gel | Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime. |
- Pro-ocular™ topical gel (Drug): Topical gel for forehead dermal application
- Placebo topical gel (Drug): Topical gel for forehead dermal application
+Outcome measures
Primary outcomes
- Modified SANDE Questionnaire - Frequency, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
- Corneal Fluorescein Stain - Central, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
Secondary outcomes
- Modified SANDE Questionnaire - Frequency, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
- Modified SANDE Questionnaire - Frequency, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
- Corneal Fluorescein Stain - Central, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Central, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
- Modified SANDE Questionnaire - Global, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
- Modified SANDE Questionnaire - Global, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
- Modified SANDE Questionnaire - Global, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes.
Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.
- Corneal Fluorescein Stain - Total, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Total, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Total, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
- Blurred Vision, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.
Blurred vision symptom is reported by participant.
- Blurred Vision, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.
Blurred vision symptom is reported by participant.
- Blurred Vision, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes.
Blurred vision symptom is reported by participant.
- Photophobia, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.
Sensitivity to light symptom is reported by participant.
- Photophobia, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.
Sensitivity to light symptom is reported by participant.
- Photophobia, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes.
Sensitivity to light symptom is reported by participant.
- Lid Edema, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid edema is viewed by slit lamp without stain.
- Lid Edema, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid edema is viewed by slit lamp without stain.
- Lid Edema, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid edema is viewed by slit lamp without stain.
- Lid Erythema, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is viewed by slit lamp without stain.
- Lid Erythema, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is viewed by slit lamp without stain.
- Lid Erythema, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is viewed by slit lamp without stain.
- Lid Margin Ulceration, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid margin ulceration is viewed by slit lamp without stain.
- Lid Margin Ulceration, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid margin ulceration is viewed by slit lamp without stain.
- Lid Margin Ulceration, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Lid margin ulceration is viewed by slit lamp without stain.
- Conjunctival Hyperemia, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Conjunctival hyperemia is viewed by slit lamp without stain.
- Conjunctival Hyperemia, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Conjunctival hyperemia is viewed by slit lamp without stain.
- Conjunctival Hyperemia, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Conjunctival hyperemia is viewed by slit lamp without stain.
- Dryness, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Dryness symptom is reported by participant.
- Dryness, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Dryness symptom is reported by participant.
- Dryness, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Dryness symptom is reported by participant.
- Ocular Pain, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Ocular pain symptom is reported by participant.
- Ocular Pain, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Ocular pain symptom is reported by participant.
- Ocular Pain, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Ocular pain symptom is reported by participant.
- Airflow Sensitivity, Change From Baseline [2 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Airflow sensitivity symptom is reported by participant.
- Airflow Sensitivity, Change From Baseline [6 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Airflow sensitivity symptom is reported by participant.
- Airflow Sensitivity, Change From Baseline [10 weeks]: Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes.
Airflow sensitivity symptom is reported by participant.
Other outcomes
- Modified SANDE Questionnaire - Frequency [1 year]: Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
- Modified SANDE Questionnaire - Frequency [2 years]: Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?
- Modified SANDE Questionnaire - Global [1 year]: Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
- Modified SANDE Questionnaire - Global [2 years]: Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?
- Corneal Fluorescein Stain - Central [1 year]: Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Central [2 years]: Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Total [1 year]: Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
- Corneal Fluorescein Stain - Total [2 years]: Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.
- Blurred Vision [1 year]: Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.
Blurred vision symptom is reported by participant.
- Blurred Vision [2 years]: Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes.
Blurred vision symptom is reported by participant.
- Lid Edema [1 year]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Lid Edema [2 years]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Lid Erythema [1 year]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Lid Erythema [2 years]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Lid Ulceration [1 year]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Lid Ulceration [2 years]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Conjunctival Hyperemia [1 year]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
- Conjunctival Hyperemia [2 years]: Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes.
Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
1. Male or female of any race, at least 18 years of age at Visit 1 Screening.
2. Has the diagnosis of chronic ocular GvHD.
3. Has an NIH Consensus Eye Score of at least 2.
4. On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
5. One or more signs from the list of chronic ocular GvHD signs below
6. Has provided verbal and written informed consent.
7. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.
Exclusion Criteria:
1. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
2. Anticipate major changes in systemic GvHD management during study period.
3. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.
4. Anticipate change of vision correction or anticipate any ocular procedures during study period.
5. A woman who is pregnant, nursing an infant, or planning a pregnancy.
6. A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.
7. Has a known adverse reaction and/or sensitivity to the study drug or its components.
8. Unwilling to cease the use of sunscreen on the forehead or eye area.
9. Intraocular pressure >22 mm Hg at screening visit with or without ongoing glaucoma treatment.
10. Currently enrolled in an investigational drug or device study for chronic ocular GvHD.
+Posted results
Participant flow
| Milestone | Pro-ocular™ | Placebo |
|---|
| Started | 22 | 11 |
| Completed | 21 | 11 |
| Not completed | 1 | 0 |
Outcome results
- Modified SANDE Questionnaire - Frequency, Change From Baseline (Primary), Least squares mean, score on a scale: Pro-ocular™ -22.00 +/- 4.246; Placebo -4.59 +/- 6.009 (p 0.0197)
- Corneal Fluorescein Stain - Central, Change From Baseline (Primary), Least squares mean, score on a scale: Pro-ocular™ -0.90 +/- 0.213; Placebo 0.20 +/- 0.304 (p 0.0039)
- Modified SANDE Questionnaire - Frequency, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -31.75 +/- 4.313; Placebo -1.95 +/- 6.009 (p <0.0001)
- Modified SANDE Questionnaire - Frequency, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -30.72 +/- 4.313; Placebo -2.18 +/- 6.009 (p 0.0002)
- Corneal Fluorescein Stain - Central, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -0.93 +/- 0.216; Placebo -0.01 +/- 0.304 (p 0.0138)
- Corneal Fluorescein Stain - Central, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -1.18 +/- 0.216; Placebo 0.06 +/- 0.307 (p 0.0014)
- Modified SANDE Questionnaire - Global, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -16.02 +/- 4.063; Placebo -3.78 +/- 5.753 (p 0.0849)
- Modified SANDE Questionnaire - Global, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -26.35 +/- 4.128; Placebo -5.64 +/- 5.753 (p 0.0041)
- Modified SANDE Questionnaire - Global, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -25.87 +/- 4.128; Placebo -1.04 +/- 0.006 (p 0.0006)
- Corneal Fluorescein Stain - Total, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -2.53 +/- 0.527; Placebo -0.23 +/- 0.753 (p 0.0143)
- Corneal Fluorescein Stain - Total, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -3.28 +/- 0.537; Placebo -1.35 +/- 0.753 (p 0.0398)
- Corneal Fluorescein Stain - Total, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -3.97 +/- 0.537; Placebo -1.54 +/- 0.763 (p -3.97)
- Blurred Vision, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -2.07 +/- 0.400; Placebo 0.40 +/- 0.568 (p 0.0005)
- Blurred Vision, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -2.09 +/- 0.404; Placebo 0.39 +/- 0.568 (p 0.0005)
- Blurred Vision, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -2.23 +/- 0.404; Placebo -0.31 +/- 0.568 (p 0.0067)
- Photophobia, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -1.23 +/- 0.432; Placebo 0.18 +/- 0.695 (p 0.0636)
- Photophobia, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -1.68 +/- 0.437; Placebo 0.62 +/- 0.613 (p 0.0028)
- Photophobia, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -1.82 +/- 0.437; Placebo 0.01 +/- 0.612 (p 0.0067)
- Lid Edema, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -1.73 +/- 0.206; Placebo -0.80 +/- 0.293 (p 0.0105)
- Lid Edema, Change From Baseline (Secondary), Least squares mean, score on a scale: Pro-ocular™ -2.21 +/- 0.210; Placebo -0.98 +/- 0.293 (p 0.0010)
- 37 more outcome measures not shown.
Adverse events
Time frame: 2 years
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Pro-ocular™ for 2 Years | 1/22 (4.5%) | 8/22 (36.4%) | 21/22 (95.5%) |
| Pro-ocular™ for 10-week Masked Period Only | 0/22 (0.0%) | 0/22 (0.0%) | 17/22 (77.3%) |
| Placebo+Active for 2 Years Total | 1/11 (9.1%) | 7/11 (63.6%) | 11/11 (100.0%) |
| Placebo for 10-week Masked Period Ony | 0/11 (0.0%) | 2/11 (18.2%) | 8/11 (72.7%) |
Serious adverse events by term
| Term | Organ system | Pro-ocular™ for 2 Years | Pro-ocular™ for 10-week Masked Period Only | Placebo+Active for 2 Years Total | Placebo for 10-week Masked Period Ony |
|---|
| Sepsis | Infections and infestations | 0/22 | 0/22 | 1/11 | 2/11 |
| Nephrolithiasis | Renal and urinary disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Acute lymphocytic leukaemia recurrent | Blood and lymphatic system disorders | 1/22 | 0/22 | 1/11 | 0/11 |
| Endocrine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/22 | 0/22 | 1/11 | 0/11 |
| Vascular operation | Surgical and medical procedures | 1/22 | 0/22 | 0/11 | 0/11 |
| Small bowel obstruction | Gastrointestinal disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Hip surgery | Surgical and medical procedures | 1/22 | 0/22 | 0/11 | 0/11 |
| Dysphagia | Gastrointestinal disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Dyspnea | Cardiac disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Rib fracture | Musculoskeletal and connective tissue disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Cardiopulmonary failure | Cardiac disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Iron deficiency anemia | Blood and lymphatic system disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Corneal perforation | Eye disorders | 0/22 | 0/22 | 1/11 | 1/11 |
| Corneal thinning | Eye disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Corneal epithelium defect | Eye disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Mycardial infarction | Cardiac disorders | 1/22 | 0/22 | 1/11 | 1/11 |
| Cerebrovascular accident | Vascular disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Atrial fibrillation | Cardiac disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Angina unstable | Cardiac disorders | 1/22 | 0/22 | 0/11 | 0/11 |
| Neurosensory hypoacusis | Ear and labyrinth disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Ophthalmic herpes simplex | Eye disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Corneal infiltrates | Eye disorders | 0/22 | 0/22 | 1/11 | 0/11 |
| Parathyroidectomy | Surgical and medical procedures | 1/22 | 0/22 | 0/11 | 0/11 |
Other adverse events by term
| Term | Organ system | Pro-ocular™ for 2 Years | Pro-ocular™ for 10-week Masked Period Only | Placebo+Active for 2 Years Total | Placebo for 10-week Masked Period Ony |
|---|
| Headache | Nervous system disorders | 6/22 | 6/22 | 1/11 | 1/11 |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | 6/22 | 6/22 | 0/11 | 0/11 |
| Conjunctival haemorrhage | Eye disorders | 2/22 | 1/22 | 0/11 | 0/11 |
| Corneal abrasion | Eye disorders | 2/22 | 1/22 | 1/11 | 1/11 |
| Eye pain | Eye disorders | 2/22 | 2/22 | 2/11 | 2/11 |
| Eye pruritus | Eye disorders | 2/22 | 2/22 | 1/11 | 0/11 |
| Vitreous floaters | Eye disorders | 2/22 | 1/22 | 0/11 | 0/11 |
| Ocular hyperaemia | Eye disorders | 0/22 | 0/22 | 2/11 | 3/11 |
| Nausea | Gastrointestinal disorders | 2/22 | 2/22 | 1/11 | 1/11 |
| Discomfort | General disorders | 2/22 | 2/22 | 0/11 | 0/11 |
| Fall | Injury, poisoning and procedural complications | 2/22 | 0/22 | 1/11 | 0/11 |
| Dysphagia | Gastrointestinal disorders | 1/22 | 1/22 | 1/11 | 0/11 |
| Fatigue | General disorders | 1/22 | 1/22 | 1/11 | 1/11 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1/22 | 1/22 | 2/11 | 1/11 |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | 1/22 | 1/22 | 1/11 | 0/11 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Massachusetts Eye and Ear Longwood | Boston, Massachusetts | United States | |
+Publications
- Results publication: Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14. PMID 33942724
+Study documents
+Investigators