Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037661
• Other study ID #: 03-108
• 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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• INS365 Ophthalmic Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.