Not Signed In -
Fluorometholone Ophthalmic Drops or Ointment |
Eflone; Flarex; Fluor-Op; FML; FML Forte |
Clinical Trial: Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients with Dry Eye
This study has been completed.
|
Purpose
Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Keratoconjunctivitis Sicca | Drug: INS365 Ophthalmic Solution | Phase III |
MedlinePlus related topics: Eye Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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
Further Study Details:
Expected Total Enrollment: 200
Study start: April 2002; Study completion: March 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
- not had LASIK surgery
- not had punctal occlusion or cauterization within last 3 months
Location Information
Massachusetts
Ophthalmic Research Associates, Inc., Andover, Massachusetts, 01810, United States
More Information
Study ID Numbers: 03-108
Record last reviewed: August 2003
Last Updated: October 13, 2004
Record first received: May 18, 2002
ClinicalTrials.gov Identifier: NCT00037661
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: August 2003
Last Updated: October 13, 2004
Record first received: May 18, 2002
ClinicalTrials.gov Identifier: NCT00037661
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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