Study of Cyclosporine in Post-LASIK Patients

This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.

Study Overview

• Status: Completed
• Conditions: Laser In Situ Keratomileusis
• Intervention / Treatment: Drug: Cyclosporine 0.010% eye drops; Drug: Cyclosporine 0.005% eye drops; Drug: Placebo (Vehicle for Cyclosporine)

• Study Type: Interventional
• Enrollment (Actual): 621
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Previous use of RESTASIS®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyclosporine 0.010% eye drops; Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.	Drug: Cyclosporine 0.010% eye drops; Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Experimental: Cyclosporine 0.005% eye drops; Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.	Drug: Cyclosporine 0.005% eye drops; Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
Placebo Comparator: Placebo (Vehicle for Cyclosporine); Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.	Drug: Placebo (Vehicle for Cyclosporine); Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Cure	Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment	The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.	Months 3 to 6
Percentage of Patients With Cumulative Poor Vision	Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.	Month 3, Month 4, Month 5, Month 6
Worst Outcome Post-LASIK Surgery in Reading Speed Assessment	Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X [Number of words on card - (reading errors)]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.	Months 3 to 6

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Estimate): July 11, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Pharmaceutical Solutions; Calcineurin Inhibitors; Ophthalmic Solutions; Cyclosporine; Cyclosporins
• Other Study ID Numbers: 192371-018