Status:

COMPLETED

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

Lead Sponsor:

Allergan

Conditions:

Bilateral LASIK Surgery

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • Patients scheduled for LASIK surgery in both eyes.

Exclusion

  • 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.

Key Trial Info

Start Date :

August 20 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 18 2014

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT01886690

Start Date

August 20 2013

End Date

August 18 2014

Last Update

April 16 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

New South Wales, Australia

2

Kelowna, British Columbia, Canada