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

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

Completed

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INS365 Ophthalmic Solution

Drug

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: May 20, 2002
Registry last updated: Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed