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

NCT ID: NCT01381731

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Photorefractive Keratectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diquafosol tetrasodium ophthalmic solution 2%

topical ophthalmic solution

Group Type EXPERIMENTAL

diquafosol tetrasodium ophthalmic solution 2%

Intervention Type DRUG

opthalmic solution 2 drops in each eye QID

Placebo

saline ophthalmic solution

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

opthalmic solution 2 drops in each eye QID

Interventions

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diquafosol tetrasodium ophthalmic solution 2%

opthalmic solution 2 drops in each eye QID

Intervention Type DRUG

placebo

opthalmic solution 2 drops in each eye QID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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03-201

Identifier Type: -

Identifier Source: org_study_id