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Study of Cyclosporine in Post-LASIK Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00991458
First received: October 7, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Cyclosporine in Post-LASIK Patients

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Time to Cure [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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:
  • Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment [ Time Frame: Months 3 to 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With Cumulative Poor Vision [ Time Frame: Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: No ]
    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.

  • Worst Outcome Post-LASIK Surgery in Reading Speed Assessment [ Time Frame: Months 3 to 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 621
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991458

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00991458     History of Changes
Other Study ID Numbers: 192371-018
Study First Received: October 7, 2009
Results First Received: May 2, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Ophthalmic Solutions
Tetrahydrozoline
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Autonomic Agents
Cardiovascular Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014