Status:
COMPLETED
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Dry Eye Disease
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2000
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00680108
Start Date
September 1 1999
End Date
May 1 2000
Last Update
August 27 2015
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