Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

Innovative Medical93 enrolled

Overview

The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine, Refresh PlusDRUG

Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females \> 18 years old * Mild-moderate symptoms of dry eye prior to surgery * Scheduled to undergo bilateral LASIK or PRK * Likely to complete all study visits and able to provide informed consent Exclusion Criteria: * Prior use of topical cyclosporine within the last 1 year * Known contraindications to any study medication or ingredients * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. * Ocular disorders * Active ocular diseases or uncontrolled systemic disease * Active ocular allergies

Locations (1)

Southeastern Laser and Refractive Surgery

Greensboro, North Carolina, United States

Outcomes

Primary Outcomes

Dry Eye Symptoms

Time frame: 1.5 years

Secondary Outcomes

Dry eye signs

Time frame: 1.5 yrs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.