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

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01381731
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Photorefractive Keratectomy
 Drug: diquafosol tetrasodium ophthalmic solution 2%
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Merck:

Primary Outcome Measures:
  • Healing time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381731

Locations
United States, Louisiana
Southern Vision Institute
New Orleans, Louisiana, United States, 70115
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Karen Kuhn, Inspire Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01381731     History of Changes
Other Study ID Numbers: 03-201
Study First Received: June 23, 2011
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
post PRK wound healing

ClinicalTrials.gov processed this record on June 18, 2013