A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01212471
• Collaborator: (none)
• Enrollment: 840
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 56.1

Study Details

Study Description

Brief Summary

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Bromfenac Ophthalmic Solution A; Drug: Bromfenac Ophthalmic Solution B; Drug: Placebo Comparator	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 840 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromfenac Ophthalmic Solution A Bromfenac ophthalmic solution A	Drug: Bromfenac Ophthalmic Solution A; sterile ophthalmic solution
Experimental: Bromfenac Ophthalmic Solution B Bromfenac ophthalmic solution B	Drug: Bromfenac Ophthalmic Solution B; sterile ophthalmic solution
Placebo Comparator: Placebo Comparator Placebo Comparator	Drug: Placebo Comparator; sterile ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Mean Ocular Surface Disease Index (OSDI) Total Score [42 days]

   The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be of either gender and any race 18 years or older

Exclusion Criteria:

• Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01212471
• Other Study ID Numbers: S00007
• First Posted: Sep 30, 2010
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Bausch & Lomb Incorporated: Sign and symptoms of dry eye disease
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Bromfenac; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%	Bromfenac Ophthalmic Solution 0.03%	Placebo Comparator
Arm/Group Description	Bromfenac Ophthalmic Solution 0.06% twice a day	Bromfenac Ophthalmic Solution 0.03% twice a day	Placebo Comparator Placebo Comparator: sterile ophthalmic solution
Period Title: Overall Study
STARTED	141	140	139
COMPLETED	139	137	132
NOT COMPLETED	2	3	7

Baseline Characteristics

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%	Bromfenac Ophthalmic Solution 0.03%	Placebo Comparator	Total
Arm/Group Description	Bromfenac Ophthalmic Solution 0.06% twice a day	Bromfenac Ophthalmic Solution 0.03% twice a day	Placebo Comparator Placebo Comparator: sterile ophthalmic solution	Total of all reporting groups
Overall Participants	141	140	139	420
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	61.0	61.6	61.0	61.2
Sex: Female, Male (Count of Participants)
Female	109 77.3%	112 80%	112 80.6%	333 79.3%
Male	32 22.7%	28 20%	27 19.4%	87 20.7%

Outcome Measures

1. Primary Outcome

Title	Mean Ocular Surface Disease Index (OSDI) Total Score
Description	The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%	Bromfenac Ophthalmic Solution 0.03%	Placebo Comparator
Arm/Group Description	Bromfenac Ophthalmic Solution 0.06% twice a day	Bromfenac Ophthalmic Solution 0.03% twice a day	Placebo Comparator Placebo Comparator: sterile ophthalmic solution
Measure Participants	141	140	139
Mean (Standard Deviation) [score on a scale]	35.0 (22.23)	40.3 (25.22)	36.9 (23.24)

Adverse Events

Time Frame	10 days
Arm/Group Title	Bromfenac Ophthalmic Solution 0.06%		Bromfenac Ophthalmic Solution 0.03%		Placebo Comparator
Arm/Group Description	Bromfenac Ophthalmic Solution 0.06% twice a day		Bromfenac Ophthalmic Solution 0.03% twice a day		Placebo Comparator Placebo Comparator: sterile ophthalmic solution
All Cause Mortality
	Bromfenac Ophthalmic Solution 0.06%		Bromfenac Ophthalmic Solution 0.03%		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/141 (0%)		0/140 (0%)		0/139 (0%)
Serious Adverse Events
	Bromfenac Ophthalmic Solution 0.06%		Bromfenac Ophthalmic Solution 0.03%		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/141 (1.4%)		3/140 (2.1%)		1/139 (0.7%)
Blood and lymphatic system disorders
Anaemia	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Thrombocytopenia	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Gastrointestinal disorders
Diverticulum	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Dyspepsia	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Gastritis atrophic	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Melaena	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Nausea	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Upper Gastrointestinal Haemorrhage	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
General disorders
Adverse drug reaction	0/141 (0%)		0/140 (0%)		1/139 (0.7%)
Chest discomfort	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Fatigue	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Pyrexia	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Infections and infestations
Cellulitis	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Investigations
Liver function test abnormal	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Nervous system disorders
Carotid artery disease	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Cerebrovascular event	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Dizziness	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Syncope	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Psychiatric disorders
Agitation	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Anxiety	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Confusional state	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Mental status change	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Renal and urinary disorders
Renal failure chronic	0/141 (0%)		1/140 (0.7%)		0/139 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/141 (0.7%)		1/140 (0.7%)		0/139 (0%)
Vascular disorders
Orthostatic hypotension	1/141 (0.7%)		0/140 (0%)		0/139 (0%)
Other (Not Including Serious) Adverse Events
	Bromfenac Ophthalmic Solution 0.06%		Bromfenac Ophthalmic Solution 0.03%		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/141 (6.4%)		8/140 (5.7%)		7/139 (5%)
Eye disorders
Dry eye	9/141 (6.4%)		8/140 (5.7%)		7/139 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.