Trial · NCT00518089
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
NCT00518089, Phase 3, Completed, Allergan; results first posted 2011-11-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis. Trials, record NCT00518089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00518089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
- NCT number
- NCT00518089
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 859 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Bacterial Conjunctivitis
- Interventions
- Gatifloxacin 0.5% eye drops, placebo eye drops
- First posted
- 2007-08-20
- Last updated
- 2019-04-23
- Results first posted
- 2011-11-30
Source ClinicalTrials.gov
Registered outcomes5
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 Hyperemia and Conjunctival Discharge Up to Day 6 | 6 Days | Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia 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 Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 | Day 6 | Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia 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 Cure Up to Day 6 | 6 Days | Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 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 Clinical Improvement of Ocular Signs Up to Day 6 | 6 Days | Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye. |
| Secondary | Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 | 6 Days | Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 | Day 6 | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day). | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Microbiological Cure Up to Day 6 | 6 Days | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point). | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 | 6 Days | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point). | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 | 6 Days | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point). | Percentage of Patients | NUMBER |
| PRIMARY | Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 | 6 Days | Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point). | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group10
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 Hyperemia and Conjunctival Discharge at Day 6 | Gatifloxacin 0.5% Eye Drops | 59.6 | Percentage of Patients | ||
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 | Placebo Eye Drops | 46.7 | Percentage of Patients | ||
| Percentage of Patients With Microbiological Cure Up to Day 6 | Gatifloxacin 0.5% Eye Drops | 92.2 | Percentage of Patients | ||
| Percentage of Patients With Microbiological Cure Up to Day 6 | Placebo Eye Drops | 80.2 | Percentage of Patients | ||
| Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 | Gatifloxacin 0.5% Eye Drops | 97.0 | Percentage of Patients | ||
| Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 | Placebo Eye Drops | 92.2 | Percentage of Patients | ||
| Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 | Gatifloxacin 0.5% Eye Drops | 92.8 | Percentage of Patients | ||
| Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 | Placebo Eye Drops | 88.6 | Percentage of Patients | ||
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 | Gatifloxacin 0.5% Eye Drops | 51.8 | Percentage of Patients | ||
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6 | Placebo Eye Drops | 41.3 | 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 0.5% Eye Drops | 430 | |
| Overall Study | STARTED | Placebo Eye Drops | 429 | |
| Overall Study | COMPLETED | Gatifloxacin 0.5% Eye Drops | 402 | |
| Overall Study | COMPLETED | Placebo Eye Drops | 398 | |
| Overall Study | NOT COMPLETED | Gatifloxacin 0.5% Eye Drops | 28 | |
| Overall Study | NOT COMPLETED | Placebo Eye Drops | 31 |
Source ClinicalTrials.gov
Adverse events8
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 | Eye Irritation | Eye disorders | Gatifloxacin 0.5% Eye Drops | 14 | 429 | |
| other | Eye Irritation | Eye disorders | Placebo Eye Drops | 7 | 427 | |
| other | Conjunctivitis bacterial | Infections and infestations | Gatifloxacin 0.5% Eye Drops | 5 | 429 | |
| other | Conjunctivitis bacterial | Infections and infestations | Placebo Eye Drops | 19 | 427 | |
| serious | Anxiety | Psychiatric disorders | Gatifloxacin 0.5% Eye Drops | 1 | 429 | |
| serious | Anxiety | Psychiatric disorders | Placebo Eye Drops | 0 | 427 | |
| serious | Depression | Psychiatric disorders | Gatifloxacin 0.5% Eye Drops | 1 | 429 | |
| serious | Depression | Psychiatric disorders | Placebo Eye Drops | 0 | 427 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gatifloxacin 0.5% Eye Drops | ||
| Total, all-cause mortality | Placebo Eye Drops | ||
| Total, other adverse events | Gatifloxacin 0.5% Eye Drops | 19 | 429 |
| Total, other adverse events | Placebo Eye Drops | 26 | 427 |
| Total, serious adverse events | Gatifloxacin 0.5% Eye Drops | 2 | 429 |
| Total, serious adverse events | Placebo Eye Drops | 0 | 427 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25244402 | BACKGROUND |
Source PubMed
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 0.5% Eye Drops vs Placebo Eye Drops: 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/NCT00518089
GET https://conductscience.org/api/trials/v1/NCT00518089/registered