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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00518089
• Collaborator: (none)
• Enrollment: 859
• Locations: 2
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 429.5
• Patients Per Site Per Month: 39

Study Details

Study Description

Brief Summary

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis	Drug: Gatifloxacin 0.5% eye drops; Drug: placebo eye drops	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 859 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gatifloxacin 0.5% Eye Drops Gatifloxacin 0.5% Eye Drops	Drug: Gatifloxacin 0.5% eye drops; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Placebo Comparator: Placebo Eye Drops Placebo Eye Drops	Drug: placebo eye drops; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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).

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

• Signs and/or symptoms of conjunctivitis for more than 96 hours

• Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis

• Clinical diagnosis of chlamydia in either eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Downey	California	United States
2		Rajajinagar	Bangalore	India

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00518089
• Other Study ID Numbers: 198782-005
• First Posted: Aug 20, 2007
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis; Gatifloxacin; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Period Title: Overall Study
STARTED	430	429
COMPLETED	402	398
NOT COMPLETED	28	31

Baseline Characteristics

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	430	429	859
Age, Customized (participants) [Number]
1-18 years	66 15.3%	74 17.2%	140 16.3%
19-65 years	316 73.5%	313 73%	629 73.2%
>65 years	48 11.2%	42 9.8%	90 10.5%
Sex: Female, Male (Count of Participants)
Female	183 42.6%	156 36.4%	339 39.5%
Male	247 57.4%	273 63.6%	520 60.5%

Outcome Measures

1. Secondary Outcome

Title	Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Description	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).
Time Frame	Day 6

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Measure Participants	166	167
Number [Percentage of Patients]	59.6	46.7

2. Secondary Outcome

Title	Percentage of Patients With Microbiological Cure Up to Day 6
Description	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).
Time Frame	6 Days

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Measure Participants	166	167
Number [Percentage of Patients]	92.2	80.2

3. Secondary Outcome

Title	Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6
Description	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.
Time Frame	6 Days

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Measure Participants	166	167
Number [Percentage of Patients]	97.0	92.2

4. Secondary Outcome

Title	Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6
Description	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.
Time Frame	6 Days

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Measure Participants	166	167
Number [Percentage of Patients]	92.8	88.6

5. Primary Outcome

Title	Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6
Description	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).
Time Frame	6 Days

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Gatifloxacin 0.5% Eye Drops	Placebo Eye Drops
Arm/Group Description
Measure Participants	166	167
Number [Percentage of Patients]	51.8	41.3

Adverse Events

Adverse Event Reporting Description	Safety Population used for serious adverse event and adverse event analysis - defined as all patients who were randomized AND treated.
Arm/Group Title	Gatifloxacin 0.5% Eye Drops		Placebo Eye Drops
Arm/Group Description
All Cause Mortality
	Gatifloxacin 0.5% Eye Drops		Placebo Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gatifloxacin 0.5% Eye Drops		Placebo Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/429 (0.5%)		0/427 (0%)
Psychiatric disorders
Anxiety	1/429 (0.2%)		0/427 (0%)
Depression	1/429 (0.2%)		0/427 (0%)
Other (Not Including Serious) Adverse Events
	Gatifloxacin 0.5% Eye Drops		Placebo Eye Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/429 (4.4%)		26/427 (6.1%)
Eye disorders
Eye Irritation	14/429 (3.3%)		7/427 (1.6%)
Infections and infestations
Conjunctivitis bacterial	5/429 (1.2%)		19/427 (4.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.