| Registry | NCT00464438 |
|---|
| Status | Completed |
|---|
| Phase | Phase 4 |
|---|
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
|---|
| Enrollment | 171 (Actual) |
|---|
| Sponsor | Allergan (Industry) |
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| Conditions | Bacterial Conjunctivitis |
|---|
| Interventions | gatifloxacin, moxifloxacin 0.5% eye drops (Drug) |
|---|
| Dates | start 2007-06-01, primary completion 2008-09-01, completion 2008-09-01, first posted 2007-04-23, last updated 2011-09-21 |
|---|
| Locations | 2 sites in United States, Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Bacterial Conjunctivitis All trials of gatifloxacin All trials of moxifloxacin 0.5% eye drops
-Summary
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 1 | Experimental | Drug: gatifloxacin | |
| 2 | Active comparator | Drug: gatifloxacin; Drug: moxifloxacin 0.5% eye drops | |
- gatifloxacin (Drug), also known as Zymar®: Day 1-6 = 1 drop of study medication three times a day
- moxifloxacin 0.5% eye drops (Drug), also known as Vigamox®: Day 1-6 = 1 drop of study medication three times a day
+Outcome measures
Primary outcomes
- Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 [Day 7]: Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Secondary outcomes
- Percentage of Patients With Microbiological Improvement [Day 7]: Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).
- Percentage of Patients With Improvement in Ocular Signs for Lid Erythema [Days 7]: Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
- Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 [Day 7]: Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,
+3=severe).
+Eligibility
Sex: All, ages: any to 31 Days
Inclusion Criteria:
* diagnosed with bacterial conjunctivitis
Exclusion Criteria:
* chemical or foreign body trauma to either eye
* infection in either eye (besides bacterial conjunctivitis)
* white spots in the cornea or ulcers in either eye
* clinical diagnosis of chlamydia or gonorrhea in either eye
+Posted results
Participant flow
| Milestone | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|
| Started | 85 | 86 |
| Completed | 83 | 80 |
| Not completed | 2 | 6 |
Outcome results
- Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 (Primary), Number, Percentage of Patients: Gatifloxacin 0.3% 78.6; Moxifloxacin 0.5% 84.4
- Percentage of Patients With Microbiological Improvement (Secondary), Number, Percentage of Patients: Gatifloxacin 0.3% 94.6; Moxifloxacin 0.5% 92.2
- Percentage of Patients With Improvement in Ocular Signs for Lid Erythema (Secondary), Number, Percentage of Patients: Gatifloxacin 0.3% 76.8; Moxifloxacin 0.5% 75.0
- Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 (Secondary), Number, Percentage of Patients: Gatifloxacin 0.3% 94.6; Moxifloxacin 0.5% 92.2
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Gatifloxacin 0.3% | 0 | 0/84 (0.0%) | 11/84 (13.1%) |
| Moxifloxacin 0.5% | 0 | 1/86 (1.2%) | 8/86 (9.3%) |
Serious adverse events by term
| Term | Organ system | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|
| Pyrexia | Gastrointestinal disorders | 0/84 | 1/86 |
Other adverse events by term
| Term | Organ system | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|
| Conjunctivitis | Eye disorders | 4/84 | 3/86 |
| Conjunctivitis bacterial | Infections and infestations | 7/84 | 5/86 |
+Locations (2)
| Facility | City | Country | Status |
|---|
| Sacramento, California | United States | |
| Whitby, Ontario | Canada | |
+Investigators
- Medical Director, Study director, Allergan