Trial Outcomes & Findings for A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis (NCT NCT00509873)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

578 participants

Primary outcome timeframe

Day 6

Results posted on

2011-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Gatifloxacin 0.5% Eye Drops Gatifloxacin 0.5% eye drops	Placebo Eye Drops Placebo eye drops
Overall Study STARTED	287	291
Overall Study COMPLETED	276	276
Overall Study NOT COMPLETED	11	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gatifloxacin 0.5% Eye Drops n=287 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=291 Participants Placebo eye drops	Total n=578 Participants Total of all reporting groups
Age, Customized 1-18 years	123 participants n=5 Participants	123 participants n=7 Participants	246 participants n=5 Participants
Age, Customized 19-65 years	126 participants n=5 Participants	141 participants n=7 Participants	267 participants n=5 Participants
Age, Customized >65 years	38 participants n=5 Participants	27 participants n=7 Participants	65 participants n=5 Participants
Sex: Female, Male Female	161 Participants n=5 Participants	172 Participants n=7 Participants	333 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	119 Participants n=7 Participants	245 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 6

Population: 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 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).

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=167 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=158 Participants Placebo eye drops
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6	74.9 Percentage of Patients	65.2 Percentage of Patients

SECONDARY outcome

Timeframe: Day 6

Population: 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 with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at 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)

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=167 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=158 Participants Placebo eye drops
Percentage of Patients With Microbiological Cure at Day 6	89.2 Percentage of Patients	61.4 Percentage of Patients

SECONDARY outcome

Timeframe: Day 6

Population: 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 with clinical improvement of ocular signs at 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.

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=167 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=158 Participants Placebo eye drops
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6	97.0 Percentage of Patients	96.2 Percentage of Patients

SECONDARY outcome

Timeframe: Day 6

Population: 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 with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) 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

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=167 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=158 Participants Placebo eye drops
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6	85.5 Percentage of Patients	82.2 Percentage of Patients

POST_HOC outcome

Timeframe: 6 Days

Population: 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 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). (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).

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=167 Participants Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=158 Participants Placebo eye drops
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6	64.1 Percentage of Patients	50.0 Percentage of Patients

Adverse Events

Gatifloxacin 0.5% Eye Drops

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Eye Drops

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gatifloxacin 0.5% Eye Drops n=288 participants at risk Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=289 participants at risk Placebo eye drops
Cardiac disorders Cardiac failure congestive	0.00% 0/288 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated based on actual treatment received.	0.35% 1/289 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated based on actual treatment received.

Other adverse events

Other adverse events
Measure	Gatifloxacin 0.5% Eye Drops n=288 participants at risk Gatifloxacin 0.5% eye drops	Placebo Eye Drops n=289 participants at risk Placebo eye drops
Infections and infestations Conjunctivitis bacterial	4.9% 14/288 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated based on actual treatment received.	4.5% 13/289 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated based on actual treatment received.

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: (714) 246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER