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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01381731

Enrollment

Registered

2011-06-27

Start date

2005-04-30

Completion date

2005-06-30

Last updated

2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photorefractive Keratectomy

Keywords

post PRK wound healing

Brief 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.

Interventions

DRUGdiquafosol tetrasodium ophthalmic solution 2%

opthalmic solution 2 drops in each eye QID

DRUGplacebo

opthalmic solution 2 drops in each eye QID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Healing time	12 weeks

Secondary

Measure	Time frame
Adverse events	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026