Skip to main content
OpenTrials
Completed

NCT Number: NCT00611403

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)

Drug

Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery

Artificial Tears REFRESH ENDURA®

Drug

REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Primary outcomes

  1. Percentage of Patients With Clinical Success at Month 6

    Time frame: 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 outcomes

  1. Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6

    Time frame: Baseline, 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).

  2. Change From Baseline in Goblet Cell Density of the Eyes at Month 6

    Time frame: Baseline, 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 8, 2008
Registry last updated
Dec 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.