Dry Eye DiseasePhase 3NCT00600288
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)
A Phase 3 study testing diquafosol tetrasodium Ophthalmic Solution, 2% in people with Dry Eye Disease, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- diquafosol tetrasodium Ophthalmic Solution, 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study procedures being performed.
- Have a best corrected visual acuity (BCVAof +0.7 or better.
- Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
- Have ongoing dry eye disease, in the same qualifying eye or both eyes.
Who cannot join
- Have previously had LASIK refractive surgery.
- Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
- Have had penetrating intraocular surgery in the past 90 days.
- Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
- Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
- Any serious ocular systemic disease or uncontrolled medical condition.
- Exposure to any investigational drug within 30 days of study start.
About this study
Official title: A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
- Conditions
- Dry Eye Disease
- Being tested
- diquafosol tetrasodium Ophthalmic Solution, 2%, Non-preserved saline solution (Placebo)
- Medical subject headings
- Dry Eye Syndromes
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
1-2 drops administered in each eye 4 times a day for 6 weeks
Non-preserved saline solution (Placebo)Drug
1-2 drops administered in each eye 4 times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: diquafosol tetrasodium Ophthalmic Solution, 2% |
| 2 | Placebo comparator | Not described Receives: Drug: Non-preserved saline solution (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fluorescein staining scores of the cornea
Measured: 6 weeks
Secondary outcomes (1)
Safety and Tolerability
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saiid Davari, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600288
- Sponsor's protocol ID
- P08634
- Other IDs
- 03-111
- Status last verified
- Dec 2014
- First submitted
- 11 Jan 2008
- Last updated
- 9 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT00600288
- Acronym / sponsor ID
- P08634
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 24 Jan 2008 (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 purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
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 |
|---|---|---|
| 1 | Experimental | Drug: diquafosol tetrasodium Ophthalmic Solution, 2% |
| 2 | Placebo comparator | Drug: Non-preserved saline solution (Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent prior to any study procedures being performed.
- Have a best corrected visual acuity (BCVAof +0.7 or better.
- Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
- Have ongoing dry eye disease, in the same qualifying eye or both eyes.
Key exclusion criteria (7 listed)
- Have previously had LASIK refractive surgery.
- Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
- Have had penetrating intraocular surgery in the past 90 days.
- Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
- Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
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%1-2 drops administered in each eye 4 times a day for 6 weeks | Drug | 1 |
| Non-preserved saline solution (Placebo)1-2 drops administered in each eye 4 times a day for 6 weeks | Drug | 2 |
Primary outcome
Change in fluorescein staining scores of the cornea
Time frame: 6 weeks
1 secondary outcome
Safety and Tolerability
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Saiid Davari study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diquafosol tetrasodium Ophthalmic Solution, 2% in people with Dry Eye Disease, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in fluorescein staining scores of the cornea (time frame: 6 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 9 Jan 2015.