A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

Allergan

Status and phase: Completed; Phase 3

Conditions: Bilateral LASIK Surgery

Treatments: Drug: carboxymethylcellulose sodium based eye drops; Drug: carboxymethylcellulose sodium based new eye drop formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01886690

11002X-002

Details and patient eligibility

About

This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.

Enrollment: 148 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

New Eye Drop Formulation

Experimental group

Description:

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.

Treatment:

Drug: carboxymethylcellulose sodium based new eye drop formulation

REFRESH PLUS®

Active Comparator group

Description:

1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.

Treatment:

Drug: carboxymethylcellulose sodium based eye drops