Dry Eye DiseasePhase 2NCT00680108
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
A Phase 2 study testing diquafosol tetrasodium (INS365) ophthalmic solution in people with Dry Eye Disease, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- diquafosol tetrasodium (INS365) ophthalmic solution
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to May 2000
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- Best corrected visual acuity 20/40 in each eye
- 2 out 5 specified symptoms
- Corneal fluorescein staining score greater than or equal to 3 out of 15
Who cannot join
- Unable to stop concomitant medications
- Have had intraocular surgery in previous 90 days
- Have excluded systemic or ocular disease
- Wear contact lenses and are not willing to remove them
- Have intraocular pressure greater than 22 mg Hg
About this study
Official title: A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.
The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- diquafosol tetrasodium (INS365) ophthalmic solution
- 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 (INS365) ophthalmic solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of adverse events
Ocular symptomatology
Visual acuity
Biomicroscopy
Ophthalmoscopy
Secondary outcomes (1)
Unanesthetized Schirmer test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startSep 1999
- Primary completionMay 2000
- Study completionMay 2000
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680108
- Sponsor's protocol ID
- 03-102
- Status last verified
- Aug 2015
- First submitted
- 15 May 2008
- Last updated
- 27 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT00680108
- Acronym / sponsor ID
- 03-102
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 19 May 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 study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Best corrected visual acuity 20/40 in each eye
- 2 out 5 specified symptoms
- Corneal fluorescein staining score greater than or equal to 3 out of 15
Key exclusion criteria (5 listed)
- Unable to stop concomitant medications
- Have had intraocular surgery in previous 90 days
- Have excluded systemic or ocular disease
- Wear contact lenses and are not willing to remove them
- Have intraocular pressure greater than 22 mg Hg
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 (INS365) ophthalmic solution | Drug | – |
Primary outcome
Evaluation of adverse events
Ocular symptomatology
Visual acuity
Biomicroscopy
Ophthalmoscopy
1 secondary outcome
Unanesthetized Schirmer test
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 27 Aug 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.
Clinical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diquafosol tetrasodium (INS365) ophthalmic solution 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 3 inclusion and 5 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 27 Aug 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. 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 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?
Evaluation of adverse events. The study lists 5 primary outcomes in all. 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 27 Aug 2015.