Trial Outcomes & Findings for A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis (NCT NCT00518089)

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 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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

859 participants

Primary outcome timeframe

6 Days

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Overall Study STARTED	430	429
Overall Study COMPLETED	402	398
Overall Study NOT COMPLETED	28	31

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=430 Participants	Placebo Eye Drops n=429 Participants	Total n=859 Participants Total of all reporting groups
Age, Customized 1-18 years	66 participants n=5 Participants	74 participants n=7 Participants	140 participants n=5 Participants
Age, Customized 19-65 years	316 participants n=5 Participants	313 participants n=7 Participants	629 participants n=5 Participants
Age, Customized >65 years	48 participants n=5 Participants	42 participants n=7 Participants	90 participants n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	156 Participants n=7 Participants	339 Participants n=5 Participants
Sex: Female, Male Male	247 Participants n=5 Participants	273 Participants n=7 Participants	520 Participants n=5 Participants

PRIMARY 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).

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=166 Participants	Placebo Eye Drops n=167 Participants
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6	51.8 Percentage of Patients	41.3 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 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=166 Participants	Placebo Eye Drops n=167 Participants
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6	59.6 Percentage of Patients	46.7 Percentage of Patients

SECONDARY 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 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).

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=166 Participants	Placebo Eye Drops n=167 Participants
Percentage of Patients With Microbiological Cure Up to Day 6	92.2 Percentage of Patients	80.2 Percentage of Patients

SECONDARY 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 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.

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=166 Participants	Placebo Eye Drops n=167 Participants
Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6	97.0 Percentage of Patients	92.2 Percentage of Patients

SECONDARY 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 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.

Outcome measures

Outcome measures
Measure	Gatifloxacin 0.5% Eye Drops n=166 Participants	Placebo Eye Drops n=167 Participants
Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6	92.8 Percentage of Patients	88.6 Percentage of Patients

Adverse Events

Gatifloxacin 0.5% Eye Drops

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo Eye Drops

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gatifloxacin 0.5% Eye Drops n=429 participants at risk	Placebo Eye Drops n=427 participants at risk
Psychiatric disorders Anxiety	0.23% 1/429 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.	0.00% 0/427 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.
Psychiatric disorders Depression	0.23% 1/429 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.	0.00% 0/427 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.

Other adverse events

Other adverse events
Measure	Gatifloxacin 0.5% Eye Drops n=429 participants at risk	Placebo Eye Drops n=427 participants at risk
Eye disorders Eye Irritation	3.3% 14/429 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.	1.6% 7/427 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.
Infections and infestations Conjunctivitis bacterial	1.2% 5/429 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.	4.4% 19/427 Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.

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