Keratoconjunctivitis Sicca Clinical Trial
Official title:
Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye
Verified date | October 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.
Status | Completed |
Enrollment | 222 |
Est. completion date | March 2003 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months - had intermittent or regular artificial tear use within past 3 months Exclusion Criteria: - had LASIK surgery - had punctal occlusion or cauterization within last 3 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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