Photorefractive KeratectomyPhase 2NCT01381731
A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)
A Phase 2 study testing diquafosol tetrasodium ophthalmic solution 2% in people with Photorefractive Keratectomy, run by Merck Sharp & Dohme LLC.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Photorefractive Keratectomy
- What is being tested?
- diquafosol tetrasodium ophthalmic solution 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between age 18 - 45 years old
- candidate for bilateral PRK
Who cannot join
- dry eye disease
- any corneal pathologies
- previous corneal or intraocular surgeries
About this study
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.
- Conditions
- Photorefractive Keratectomy
- Being tested
- diquafosol tetrasodium ophthalmic solution 2%, placebo
- Keywords
- post PRK wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diquafosol tetrasodium ophthalmic solution 2%Drug
opthalmic solution 2 drops in each eye QID
placeboDrug
opthalmic solution 2 drops in each eye QID
| Study group | Role | What they receive |
|---|---|---|
| Diquafosol tetrasodium ophthalmic solution 2% | Experimental | topical ophthalmic solution Receives: Drug: diquafosol tetrasodium ophthalmic solution 2% |
| Placebo | Placebo comparator | saline ophthalmic solution Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Measured: 12 weeks
Secondary outcomes (1)
Adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startApr 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photorefractive KeratectomyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381731
- Sponsor's protocol ID
- 03-201
- Status last verified
- Oct 2015
- First submitted
- 23 Jun 2011
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)
- ClinicalTrials.gov ID
- NCT01381731
- Acronym / sponsor ID
- 03-201
- Conditions
- Photorefractive Keratectomy
- Keywords
- post PRK wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diquafosol tetrasodium ophthalmic solution 2% | Experimental | Drug: diquafosol tetrasodium ophthalmic solution 2%topical ophthalmic solution |
| Placebo | Placebo comparator | Drug: placebosaline ophthalmic solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between age 18 - 45 years old
- candidate for bilateral PRK
Key exclusion criteria (3 listed)
- dry eye disease
- any corneal pathologies
- previous corneal or intraocular surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diquafosol tetrasodium ophthalmic solution 2%opthalmic solution 2 drops in each eye QID | Drug | Diquafosol tetrasodium ophthalmic solution 2% |
| placeboopthalmic solution 2 drops in each eye QID | Drug | Placebo |
Primary outcome
Healing time
Time frame: 12 weeks
1 secondary outcome
Adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diquafosol tetrasodium ophthalmic solution 2% in people with Photorefractive Keratectomy, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.