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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01381731
First received: June 23, 2011
Last updated: October 29, 2015
Last verified: October 2015
  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 Sharp & Dohme Corp.:

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
Study Completion Date: June 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01381731     History of Changes
Other Study ID Numbers: 03-201 
Study First Received: June 23, 2011
Last Updated: October 29, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions

ClinicalTrials.gov processed this record on August 25, 2016