Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
1 other identifier
interventional
137
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
December 20, 2011
CompletedDecember 20, 2011
November 1, 2011
1 year
January 28, 2008
November 17, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Baseline, Month 6
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Baseline, Month 6
Study Arms (2)
RESTASIS®
ACTIVE COMPARATORCyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®
ACTIVE COMPARATORArtificial Tears (REFRESH ENDURA®)
Interventions
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
Eligibility Criteria
You may qualify if:
- Patient is scheduled for bilateral LASIK surgery
- Patient is in good general health
- Eye glasses prescription of -1 to -8
You may not qualify if:
- Significant Dry Eye
- Presence of eye disease
- Uncontrolled systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Overland Park, Kansas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 8, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
December 20, 2011
Results First Posted
December 20, 2011
Record last verified: 2011-11