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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Photorefractive Keratectomy

Treatments: Drug: diquafosol tetrasodium ophthalmic solution 2%; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01381731

03-201

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

Diquafosol tetrasodium ophthalmic solution 2%

Experimental group

Description:

topical ophthalmic solution

Treatment:

Drug: diquafosol tetrasodium ophthalmic solution 2%

Placebo

Placebo Comparator group

Description:

saline ophthalmic solution

Treatment:

Drug: placebo