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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00037661
Other study ID # 03-108
Secondary ID
Status Completed
Phase Phase 3
First received May 18, 2002
Last updated October 1, 2015
Start date April 2002
Est. completion date March 2003

Study information

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

Clinical Trial Summary

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
INS365 Ophthalmic Solution


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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