CompletedInterventionalPhase 3Updated Nov 17, 2017
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery | NCT01886690 | Trialant
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
ClinicalTrials.gov ID
NCT01886690
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
148Actual
Last Update Posted
Apr 16, 2019Actual
Start Date
Aug 20, 2013Actual
Primary Completion Date
Aug 18, 2014Actual
Completion Date
Aug 18, 2014Actual
Brief Summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Bilateral LASIK Surgery
carboxymethylcellulose sodium based new eye drop formulation
carboxymethylcellulose sodium based eye drops
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.