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Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349440
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:
Innovative Medical

Brief Summary:
The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Cyclosporine, Refresh Plus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Arm Intervention/treatment
Active Comparator: 1 Drug: Cyclosporine, Refresh Plus

Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.


Placebo Comparator: 2 Drug: Cyclosporine, Refresh Plus

Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.





Primary Outcome Measures :
  1. Dry Eye Symptoms [ Time Frame: 1.5 years ]

Secondary Outcome Measures :
  1. Dry eye signs [ Time Frame: 1.5 yrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females > 18 years old
  • Mild-moderate symptoms of dry eye prior to surgery
  • Scheduled to undergo bilateral LASIK or PRK
  • Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

  • Prior use of topical cyclosporine within the last 1 year
  • Known contraindications to any study medication or ingredients
  • Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
  • Ocular disorders
  • Active ocular diseases or uncontrolled systemic disease
  • Active ocular allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349440


Locations
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United States, North Carolina
Southeastern Laser and Refractive Surgery
Greensboro, North Carolina, United States, 27410
Sponsors and Collaborators
Innovative Medical
Investigators
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Principal Investigator: Karl Stonecipher, MD Southeastern Laser and Refractive Surgery
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Responsible Party: Karl Stonecipher, MD, Southeastern Laser and Refractive Surgery
ClinicalTrials.gov Identifier: NCT00349440    
Other Study ID Numbers: 1121
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008
Keywords provided by Innovative Medical:
Dry eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors