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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00611403
First received: January 28, 2008
Last updated: November 17, 2011
Last verified: November 2011

January 28, 2008
November 17, 2011
December 2007
December 2008   (final data collection date for primary outcome measure)
Percentage of Patients With Clinical Success at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
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.
corneal sensitivity [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611403 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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).
  • contrast sensitivity [ Time Frame: Months 1-6 ] [ Designated as safety issue: No ]
  • Schirmer tear test [ Time Frame: Months 1-6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Syndromes
  • Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
    Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
  • Drug: Artificial Tears REFRESH ENDURA®
    REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
  • Active Comparator: RESTASIS®
    Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
    Intervention: Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
  • Active Comparator: REFRESH ENDURA®
    Artificial Tears (REFRESH ENDURA®)
    Intervention: Drug: Artificial Tears REFRESH ENDURA®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611403
192371-014
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP