11 completed, 8 unknown, 2 terminated, 1 enrolling by invitation. 11 Phase 4, 4 Not applicable, 4 Phase 2, 4 Phase 3.
Follow Fluorometholone: new trials by email Literature Review of Fluorometholone trials Research Report on Fluorometholone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Fluorometholone Study Adjunctive Topical Fluorometholone (FML) 0.1%, Standard Topical Antibiotic Therapy - Keratitis Bacterial, Corneal Ulcer (Diagnosis) | Phase 2 | Not yet recruiting | Vishal Jhanji | 174 | 2026-10-31 | 2026-06-10 |
| Vevye + Flarex Combination Therapy for Dry Eye Vevye(Cyclosporine 0.1% Ophthalmic Solution), Flarex - Dry Eye | Phase 4 | Enrolling by invitation | Canyon City Eyecare | 60 | 2026-04-03 | 2026-04-28 |
| Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT Ketorolac 0.5% Eye Drops, Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops - Open Angle Glaucoma, Ocular Hypertension | Phase 4 | Unknown | St. Joseph's Healthcare Hamilton | 126 | 2024-09-01 | 2024-07-12 |
| The OPTIMISE Study Fluorometholone 0.1% Oph Susp, Dexamethasone 0.1% ophthalmic suspension, Stop steroids - Pseudophakic Bullous Keratopathy, Fuchs' Endothelial Dystrophy | Phase 4 | Recruiting | Maastricht University Medical Center | 342 | 2024-07-29 | 2025-10-06 |
| Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis SYSTANE™ Hydration Lubricant Eye Drops - Dry Eye Syndromes | Phase 4 | Unknown | Chang Gung Memorial Hospital | 40 | 2024-02-05 | 2024-02-06 |
| Comparison of the Postoperative Use of Dextenza vs a Standard Regimen After PRK Dextenza 0.4Mg Ophthalmic Insert, Topical Fluorometholone - Steroid Ophthalmic Insert | Phase 4 | Unknown | Navy Medical Center San Diego | 60 | 2022-10-01 | 2022-10-20 |
| Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease Fluorometholone 0.1% ophthalmic solution, Cyclosporine 0.05% eye drops - Dry Eye Disease (DED) | Phase 4 | Completed | Korea University Anam Hospital | 32 | 2022-09-01 | 2025-03-14 |
| Effect of Various Treatment Modalities on Dendritic Vial Ulcer Acyclovir, Tobramycin, Fluorometholone - Corneal Ulcer | Unknown | Sohag University | 40 | 2022-03-18 | 2022-04-06 | |
| FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial Fluorometholone 0.1% Oph Susp, Artificial Tears - Trachomatous Trichiasis (TT), Eye Diseases | Phase 3 | Completed | Massachusetts Eye and Ear Infirmary | 2410 | 2021-08-19 | 2026-03-24 |
| Tolerability Comparison of Flarex to Lotemax SM Fluorometholone Acetate Ophthalmic Suspension 0.1%, Loteprednol Etabonate Ophthalmic Gel 0.38% - Ocular Inflammation, Keratoconjunctivitis | Phase 4 | Completed | Harrow Inc | 40 | 2021-05-01 | 2026-09-22 |
| Ocular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy Fluorometholone, Functional Slit-Lamp Biomicroscopy - Dry Eye Syndromes, Inflammation | Phase 4 | Unknown | Zhongshan Ophthalmic Center, Sun Yat-sen University | 20 | 2017-06-30 | 2018-11-20 |
| Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study Fluorometholone(FML), Loteprednol (Lotemax) - Must be PRK Candidate | Phase 4 | Unknown | Dr Salouti Eye Research Center | 200 | 2017-04-01 | 2016-11-28 |
| Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis FLUCON®, Cyclosporine A eye drops 0.5% - Adenoviral Keratoconjunctivitis | Phase 4 | Completed | Military Hospital of Tunis | 51 | 2017-04-01 | 2020-05-07 |
| Ocular-hypertensive Response to Topical Steroids in Children After Bilateral Strabismus Surgery 0.1 % Dexamethasone, 0.1% Fluorometholone, 1% Rimexolone - Intraocular Pressure | Phase 4 | Completed | Cairo University | 40 | 2015-10-01 | 2016-06-29 |
| Topical Steroid Treatment For Dry Eye Loteprednol Etabonate (FML) - Dry Eye | Not applicable | Unknown | Meir Medical Center | 30 | 2014-09-01 | 2014-08-18 |
| The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements Mitomycin-C, Fluorometholone 1% topical ocular steroid - Corneal Opacity | Phase 2 / Phase 3 | Unknown | United States Naval Medical Center, San Diego | 300 | 2014-08-01 | 2022-04-15 |
| Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca) FML 0.1% eyedrops, Liquifilm artificial tears eyedrops - Dry Eye | Phase 3 | Completed | Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | 41 | 2014-02-01 | 2015-01-08 |
| Fluorometholone as Ancillary Therapy for TT Surgery Fluorometholone 0.1% ophthalmic solution, Artificial tears (Placebo) - Trichiasis, Trachoma | Not applicable | Completed | University of Pennsylvania | 154 | 2013-11-01 | 2016-04-21 |
| Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease nonsteroid anti-inflammatory drops, corticosteroids, artificial tear substitute - Moderate to Severe Dry Eye Syndrome | Not applicable | Completed | Wenzhou Medical University | 48 | 2012-03-01 | 2014-01-03 |
| Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) Prednisolone acetate, Fluorometholone - Fuchs' Dystrophy, Bullous Keratopathy | Phase 2 | Completed | Price Vision Group | 264 | 2011-10-01 | 2014-09-03 |
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Dry Eye Syndromes (7) · Corneal Diseases (3) · Corneal Ulcer (2) · Dilatation, Pathologic (2) · Inflammation (2) · Keratoconus (2) · Trichiasis (2) · Arthritis, Rheumatoid (1) · Breast Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Corneal Opacity (1) · Corneal dystrophy, Fuchs' endothelial, 1 (1) · Disease (1) · Endophthalmitis (1) · Esophageal Neoplasms (1)
Cxlusa (2) · Cairo University (1) · Canyon City Eyecare (1) · Chang Gung Memorial Hospital (1) · Dr Salouti Eye Research Center (1) · Harrow Inc (1) · Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (1) · Korea University Anam Hospital (1) · M.D. Anderson Cancer Center (1) · Maastricht University Medical Center (1) · Massachusetts Eye and Ear Infirmary (1) · Meir Medical Center (1) · Military Hospital of Tunis (1) · Navy Medical Center San Diego (1) · Price Vision Group (1)
United States (7) · China (2) · Egypt (2) · Ethiopia (2) · Belgium (1) · Canada (1) · Germany (1) · Israel (1) · Netherlands (1) · South Korea (1) · Spain (1) · Taiwan (1) · Thailand (1) · Tunisia (1)
William Trattler, MD (2) · Afef Maalej (1) · Audrey Rostov, MD (1) · Bita Esmaeli, MD (1) · Chi-Chin Sun, M.D/Ph.D (1) · Daniel Goodman, MD (1) · Donna Murdoch, Ph.D. (1) · Enitan A Sogbesan, MD (1) · Francis W Price, MD (1) · Friedrich Kruse, MD (1) · Gregg Berdy, MD (1) · Jay Schwartz, MD (1) · Jodi Luchs, MD (1) · John B Cason, M.D. (1) · John H Kempen, MD MPH MHS PhD (1)
PMID 11130165, PMID 25043311, PMID 25062336, PMID 26489119, PMID 33201059, PMID 39006430, PMID 39656933, PMID 40737343, PMID 41539314