Dry Eye Disease Clinical Trial
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
Verified date | August 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2000 |
Est. primary completion date | July 2000 |
Accepts healthy volunteers | |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Schirmer scores | |||
Primary | Corneal staining | |||
Primary | Conjunctival staining | |||
Primary | Tear break-up time | |||
Primary | Change in artificial tear usage | |||
Primary | Patient-reported improvement of foreign body sensation | |||
Secondary | Visual acuity | |||
Secondary | Investigator global severity assessment | |||
Secondary | Patient-reported dry eye symptoms other than foreign body sensation | |||
Secondary | Biomicroscopy | |||
Secondary | Ophthalmoscopy | |||
Secondary | IOP |
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