Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- carboxymethylcellulose sodium based New Eye Drop Formulation 1
- Conditions
- Dry Eye Syndromes
- Sponsor
- Allergan
- Enrollment
- 305
- Primary Endpoint
- Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current use of an artificial tear product at least twice daily for at least 3 months, on average
- •Ability/agreement to continue wearing existing spectacle correction (glasses) during study
Exclusion Criteria
- •Anticipated contact lens wear during study or contact lens use within 6 months
- •Active ocular infection or allergy
- •Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
- •Use of any topical cyclosporine products within 3 months
Arms & Interventions
New Eye Drop Formulation 1
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
Intervention: carboxymethylcellulose sodium based New Eye Drop Formulation 1
New Eye Drop Formulation 2
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Intervention: carboxymethylcellulose sodium based New Eye Drop Formulation 2
Refresh Tears®
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Intervention: carboxymethylcellulose sodium based Eye Drops
Outcomes
Primary Outcomes
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Time Frame: Baseline, Day 90
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Secondary Outcomes
- Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness(Baseline, Day 90)
- Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)(Baseline, Day 90)
- Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)(Baseline, Day 90)
- Change From Baseline in Tear Break-Up Time (TBUT)(Baseline, Day 90)
- Change From Baseline in Corneal Staining(Baseline, Day 90)
- Change From Baseline in Conjunctival Staining(Baseline, Day 90)
- Change From Baseline in Schirmer Test(Baseline, Day 90)