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A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)

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: NCT01381731
Recruitment Status : Terminated
First Posted : June 27, 2011
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The objectives of this trial are to:

  • Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK).
  • Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.

Condition or disease Intervention/treatment Phase
Photorefractive Keratectomy Drug: diquafosol tetrasodium ophthalmic solution 2% Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2005
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Diquafosol tetrasodium ophthalmic solution 2%
topical ophthalmic solution
Drug: diquafosol tetrasodium ophthalmic solution 2%
opthalmic solution 2 drops in each eye QID
Placebo Comparator: Placebo
saline ophthalmic solution
Drug: placebo
opthalmic solution 2 drops in each eye QID


Outcome Measures

Primary Outcome Measures :
  1. Healing time [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between age 18 - 45 years old
  • candidate for bilateral PRK

Exclusion Criteria:

  • dry eye disease
  • any corneal pathologies
  • previous corneal or intraocular surgeries
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01381731     History of Changes
Other Study ID Numbers: 03-201
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
post PRK wound healing

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions