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

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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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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