NCT01381731

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

November 25, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

June 23, 2011

Last Update Submit

October 29, 2015

Conditions

Photorefractive Keratectomy

Keywords

post PRK wound healing

Outcome Measures

Primary Outcomes (1)

  • Healing time

    12 weeks

Secondary Outcomes (1)

  • Adverse events

    12 weeks

Study Arms (2)

Diquafosol tetrasodium ophthalmic solution 2%

EXPERIMENTAL

topical ophthalmic solution

Drug: diquafosol tetrasodium ophthalmic solution 2%

Placebo

PLACEBO COMPARATOR

saline ophthalmic solution

Drug: placebo

Interventions

diquafosol tetrasodium ophthalmic solution 2%DRUG

opthalmic solution 2 drops in each eye QID

Diquafosol tetrasodium ophthalmic solution 2%
placeboDRUG

opthalmic solution 2 drops in each eye QID

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • between age 18 - 45 years old
  • candidate for bilateral PRK

You may not qualify if:

  • dry eye disease
  • any corneal pathologies
  • previous corneal or intraocular surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

April 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 25, 2015

Record last verified: 2015-10