Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Dry Eye Syndromes Clinical Trial

Official title:

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611403
• Other study ID #: 192371-014
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: November 17, 2011
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient is scheduled for bilateral LASIK surgery

• Patient is in good general health

• Eye glasses prescription of -1 to -8

Exclusion Criteria:

• Significant Dry Eye

• Presence of eye disease

• Uncontrolled systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
• Artificial Tears REFRESH ENDURA®
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Clinical Success at Month 6	Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.	Month 6	No
Secondary	Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6	Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).	Baseline, Month 6	No
Secondary	Change From Baseline in Goblet Cell Density of the Eyes at Month 6	Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).	Baseline, Month 6	No