Study of Cyclosporine in Post-LASIK Patients

• ClinicalTrials.gov Identifier: NCT00991458
• Recruitment Status: Completed
• First Posted: October 8, 2009
• Results First Posted: July 11, 2013
• Last Update Posted: July 11, 2013
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Laser In Situ Keratomileusis	Drug: Cyclosporine 0.010% eye drops; Drug: Cyclosporine 0.005% eye drops; Drug: Placebo (Vehicle for Cyclosporine)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 621 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of Cyclosporine in Post-LASIK Patients
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Time to Cure [ Time Frame: 6 Months ]
   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.

Secondary Outcome Measures :

1. Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment [ Time Frame: Months 3 to 6 ]
   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.
2. Percentage of Patients With Cumulative Poor Vision [ Time Frame: Month 3, Month 4, Month 5, Month 6 ]
   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.
3. Worst Outcome Post-LASIK Surgery in Reading Speed Assessment [ Time Frame: Months 3 to 6 ]
   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.

Eligibility Criteria

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

Criteria

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®

Contacts and Locations

Locations

United States, Kansas

Overland Park, Kansas, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00991458
• Other Study ID Numbers: 192371-018
• First Posted: October 8, 2009
• Results First Posted: July 11, 2013
• Last Update Posted: July 11, 2013
• Last Verified: July 2013

Additional relevant MeSH terms:

Cyclosporine; Ophthalmic Solutions; Cyclosporins; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Calcineurin Inhibitors; Pharmaceutical Solutions