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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349440
• Other study ID #: 1121
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2006
• Last updated: September 23, 2008
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine, 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.

Locations

Country	Name	City	State
United States	Southeastern Laser and Refractive Surgery	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry Eye Symptoms		1.5 years	No
Secondary	Dry eye signs		1.5 yrs	No