Back to resultsA Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
diquafosol tetrasodium (INS365) ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Evaluation of adverse events
Ocular symptomatology
Visual acuity
Biomicroscopy
Ophthalmoscopy
Secondary Outcome Measures
Unanesthetized Schirmer test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00680108
Brief Title
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
May 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
diquafosol tetrasodium (INS365) ophthalmic solution
Primary Outcome Measure Information:
Title
Evaluation of adverse events
Title
Ocular symptomatology
Title
Visual acuity
Title
Biomicroscopy
Title
Ophthalmoscopy
Secondary Outcome Measure Information:
Title
Unanesthetized Schirmer test
10. Eligibility
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
We'll reach out to this number within 24 hrs