Dry Eye DiseasePhase 2NCT00679718
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease
A Phase 2 study testing diquafosol tetrasodium (INS365) ophthalmic solution in people with Dry Eye Disease, run by Merck Sharp & Dohme LLC.
Trial summary
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jul 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 of at least +0.7 ETDRS
- Six month history of dry eye disease
- Mild severity in two out of five symptoms
- Unanesthetized Schirmer score of less than or equal to 7mm
- Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18
Who cannot join
- Nasal stimulated Schirmer score of less than 3mm
- Have ongoing ocular infection
- Have congenitally absent meibomian or lacrimal glands
- Have had punctal occlusion within a specified time prior to study
- Wear contact lens and refuse to remove them
- Have other excluded eye conditions.
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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.
Schirmer scores
Corneal staining
Conjunctival staining
Tear break-up time
Change in artificial tear usage
Patient-reported improvement of foreign body sensation
Secondary outcomes (6)
Visual acuity
Investigator global severity assessment
Patient-reported dry eye symptoms other than foreign body sensation
Biomicroscopy
Ophthalmoscopy
IOP
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 startJan 2000
- Primary completionJul 2000
- Study completionJul 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
- 150 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
- NCT00679718
- Sponsor's protocol ID
- 03-103
- 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 Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT00679718
- Acronym / sponsor ID
- 03-103
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Jul 2000 (actual)
- Study completion
- Jul 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.
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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 (5 listed)
- Best corrected visual acuity of at least +0.7 ETDRS
- Six month history of dry eye disease
- Mild severity in two out of five symptoms
- Unanesthetized Schirmer score of less than or equal to 7mm
- Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18
Key exclusion criteria (6 listed)
- Nasal stimulated Schirmer score of less than 3mm
- Have ongoing ocular infection
- Have congenitally absent meibomian or lacrimal glands
- Have had punctal occlusion within a specified time prior to study
- Wear contact lens and refuse to remove them
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
Schirmer scores
Corneal staining
Conjunctival staining
Tear break-up time
Change in artificial tear usage
Patient-reported improvement of foreign body sensation
6 secondary outcomes
Visual acuity
Investigator global severity assessment
Patient-reported dry eye symptoms other than foreign body sensation
Biomicroscopy
Ophthalmoscopy
IOP
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 5 inclusion and 6 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?
Schirmer scores. The study lists 6 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.