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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Artificial Tears REFRESH ENDURA®
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring LASIK

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RESTASIS®

REFRESH ENDURA®

Arm Description

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Artificial Tears (REFRESH ENDURA®)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
January 28, 2008
Last Updated
November 17, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00611403
Brief Title
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Official Title
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESTASIS®
Arm Type
Active Comparator
Arm Description
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Arm Title
REFRESH ENDURA®
Arm Type
Active Comparator
Arm Description
Artificial Tears (REFRESH ENDURA®)
Intervention Type
Drug
Intervention Name(s)
Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Intervention Description
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
Intervention Type
Drug
Intervention Name(s)
Artificial Tears REFRESH ENDURA®
Intervention Description
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
Primary Outcome Measure Information:
Title
Percentage of Patients With Clinical Success at Month 6
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Description
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).
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Overland Park
State/Province
Kansas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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