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OpenTrials
Completed

NCT Number: NCT00349440

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

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).

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Southeastern Laser and Refractive Surgery

Greensboro, North Carolina, 27410, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cyclosporine, Refresh Plus

Drug

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 outcomes

  1. Dry Eye Symptoms

    Time frame: 1.5 years

Secondary outcomes

  1. Dry eye signs

    Time frame: 1.5 yrs

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 7, 2006
Registry last updated
Sep 26, 2008

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.

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