Trial · NCT00464438
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
NCT00464438, Phase 4, Completed, Allergan; results first posted 2011-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis. Trials, record NCT00464438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00464438
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
- NCT number
- NCT00464438
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 171 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Bacterial Conjunctivitis
- Interventions
- gatifloxacin, moxifloxacin 0.5% eye drops
- First posted
- 2007-04-23
- Last updated
- 2011-09-21
- Results first posted
- 2011-09-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | Day 7 | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Microbiological Improvement | Day 7 | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | Days 7 | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | Day 7 | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | Gatifloxacin 0.3% | 78.6 | Percentage of Patients | ||
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | Moxifloxacin 0.5% | 84.4 | Percentage of Patients | ||
| Percentage of Patients With Microbiological Improvement | Gatifloxacin 0.3% | 94.6 | Percentage of Patients | ||
| Percentage of Patients With Microbiological Improvement | Moxifloxacin 0.5% | 92.2 | Percentage of Patients | ||
| Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | Gatifloxacin 0.3% | 76.8 | Percentage of Patients | ||
| Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | Moxifloxacin 0.5% | 75.0 | Percentage of Patients | ||
| Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | Gatifloxacin 0.3% | 94.6 | Percentage of Patients | ||
| Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | Moxifloxacin 0.5% | 92.2 | Percentage of Patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gatifloxacin 0.3% | 85 | |
| Overall Study | STARTED | Moxifloxacin 0.5% | 86 | |
| Overall Study | COMPLETED | Gatifloxacin 0.3% | 83 | |
| Overall Study | COMPLETED | Moxifloxacin 0.5% | 80 | |
| Overall Study | NOT COMPLETED | Gatifloxacin 0.3% | 2 | |
| Overall Study | NOT COMPLETED | Moxifloxacin 0.5% | 6 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | Gatifloxacin 0.3% | 4 | 84 | |
| other | Conjunctivitis | Eye disorders | Moxifloxacin 0.5% | 3 | 86 | |
| other | Conjunctivitis bacterial | Infections and infestations | Gatifloxacin 0.3% | 7 | 84 | |
| other | Conjunctivitis bacterial | Infections and infestations | Moxifloxacin 0.5% | 5 | 86 | |
| serious | Pyrexia | Gastrointestinal disorders | Gatifloxacin 0.3% | 0 | 84 | |
| serious | Pyrexia | Gastrointestinal disorders | Moxifloxacin 0.5% | 1 | 86 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gatifloxacin 0.3% | ||
| Total, all-cause mortality | Moxifloxacin 0.5% | ||
| Total, other adverse events | Gatifloxacin 0.3% | 11 | 84 |
| Total, other adverse events | Moxifloxacin 0.5% | 8 | 86 |
| Total, serious adverse events | Gatifloxacin 0.3% | 0 | 84 |
| Total, serious adverse events | Moxifloxacin 0.5% | 1 | 86 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gatifloxacin 0.3% vs Moxifloxacin 0.5%: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00464438
GET https://conductscience.org/api/trials/v1/NCT00464438/registered