Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- Carboxymethylcellulose Based Eye Drop Formulation A
- Conditions
- Dry Eye Syndromes
- Sponsor
- Allergan
- Enrollment
- 315
- Primary Endpoint
- Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
Exclusion Criteria
- •Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- •Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- •Active ocular allergy
Arms & Interventions
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Intervention: Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Intervention: Carboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Intervention: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
Intervention: Carboxymethylcellulose Based Lubricant Eye Drops
Outcomes
Primary Outcomes
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
Time Frame: Baseline, Day 30
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Secondary Outcomes
- Change From Baseline in Tear Break-up Time(Baseline, Day 30)
- Change From Baseline in Corneal Staining(Baseline, Day 30)
- Change From Baseline in Conjunctival Staining(Baseline, Day 30)
- Change From Baseline in Schirmer Test Results(Baseline, Day 30)