A Phase 4 interventional study of gatifloxacin and moxifloxacin 0.5% eye drops in Bacterial Conjunctivitis, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to participants aged Up to 31 Days. Per ClinicalTrials.gov, last updated 2011-09-21.
Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Treatment
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
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 171 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Drug: gatifloxacin
Drug: gatifloxacin · Drug: moxifloxacin 0.5% eye drops
Day 1-6 = 1 drop of study medication three times a day
Also known as: Zymar®
Day 1-6 = 1 drop of study medication three times a day
Also known as: Vigamox®
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at 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).
Time frame: Day 7
Percentage of Patients With Microbiological Improvement
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).
Time frame: Day 7
Percentage of Patients With Improvement in Ocular Signs for Lid Erythema
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).
Time frame: Days 7
Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at 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).
Time frame: Day 7
| Milestone | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Started | 85 | 86 |
| Completed | 83 | 80 |
| Not completed | 2 | 6 |
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).
| Percentage of Patients | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | 78.6 | 84.4 |
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 | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Percentage of Patients With Microbiological Improvement | 94.6 | 92.2 |
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 | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | 76.8 | 75.0 |
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).
| Percentage of Patients | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | 94.6 | 92.2 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gatifloxacin 0.3% | — | 0/84 (0%) | 11/84 (13.1%) |
| Moxifloxacin 0.5% | — | 1/86 (1.2%) | 8/86 (9.3%) |
| Event | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| PyrexiaGastrointestinal disorders | 0/84 | 1/86 |
| Event | Gatifloxacin 0.3% | Moxifloxacin 0.5% |
|---|---|---|
| Conjunctivitis bacterialInfections and infestations | 7/84 | 5/86 |
| ConjunctivitisEye disorders | 4/84 | 3/86 |
| Age Continuous(days) | Gatifloxacin 0.3% | Moxifloxacin 0.5% | Total |
|---|---|---|---|
| Mean | 15.2 ± 6.59 | 15.2 ± 6.05 | 15.2 ± 6.31 |
| Sex: Female, Male(Participants) | Gatifloxacin 0.3% | Moxifloxacin 0.5% | Total |
|---|---|---|---|
| Female | 37 | 22 | 59 |
| Male | 48 | 64 | 112 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gatifloxacin