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

Photorefractive Keratectomy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01381731
• Other study ID #: 03-201
• Status: Terminated
• Phase: Phase 2
• First received: June 23, 2011
• Last updated: October 29, 2015
• Start date: April 2005
• Est. completion date: June 2005

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Photorefractive Keratectomy

Intervention

Drug:
• diquafosol tetrasodium ophthalmic solution 2%
opthalmic solution 2 drops in each eye QID
• placebo
opthalmic solution 2 drops in each eye QID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time		12 weeks	No
Secondary	Adverse events		12 weeks	No