A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
Overview
- Phase
- Phase 3
- Intervention
- carboxymethylcellulose sodium based new eye drop formulation
- Conditions
- Bilateral LASIK Surgery
- Sponsor
- Allergan
- Enrollment
- 148
- Primary Endpoint
- Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for LASIK surgery in both eyes.
Exclusion Criteria
- •Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
- •Use of topical eye medication other than prescribed for use in pre- or post-operative care
- •Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
- •Eye infection, inflammation, or allergy
- •Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Arms & Interventions
New Eye Drop Formulation
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
Intervention: carboxymethylcellulose sodium based new eye drop formulation
REFRESH PLUS®
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Intervention: carboxymethylcellulose sodium based eye drops
Outcomes
Primary Outcomes
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
Time Frame: Day 90
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
Secondary Outcomes
- Change From Baseline in Corneal Staining in the Worse Eye(Baseline, Day 90)
- Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye(Baseline, Day 90)
- Change From Baseline in the Schirmer Test in the Worse Eye(Baseline, Day 90)
- Change From Baseline in Uncorrected Visual Acuity in the Worse Eye(Baseline, Day 90)