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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349440

Enrollment

Registered

2006-07-07

Start date

2006-09-30

Completion date

2008-09-30

Last updated

2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye

Brief summary

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).

Interventions

DRUGCyclosporine, Refresh Plus

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dry Eye Symptoms	1.5 years

Secondary

Measure	Time frame
Dry eye signs	1.5 yrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026