A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Overview
- Phase
- Phase 3
- Intervention
- carboxymethylcellulose based eye drop formula
- Conditions
- Contact Lens Lubrication
- Sponsor
- Allergan
- Enrollment
- 365
- Primary Endpoint
- Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.
Exclusion Criteria
- •Wearing monovision lenses
- •Have had refractive surgery within the previous 12 months
- •Have infection of the eye, eyelids or eye structures.
Arms & Interventions
Carboxymethylcellulose Based Eye Drop Formula
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
Intervention: carboxymethylcellulose based eye drop formula
REFRESH CONTACTS®
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
Intervention: carboxymethylcellulose sodium based eye drop solution
Outcomes
Primary Outcomes
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Time Frame: Baseline, Day 90
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.