A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Disease

• Registration Number: NCT00679718
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2000-07
• Study Completion: 2000-07
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

• Best corrected visual acuity of at least +0.7 ETDRS
• Six month history of dry eye disease
• Mild severity in two out of five symptoms
• Unanesthetized Schirmer score of less than or equal to 7mm
• Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

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Exclusion Criteria

• Nasal stimulated Schirmer score of less than 3mm
• Have ongoing ocular infection
• Have congenitally absent meibomian or lacrimal glands
• Have had punctal occlusion within a specified time prior to study
• Wear contact lens and refuse to remove them
• Have other excluded eye conditions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Schirmer scores
Corneal staining
Conjunctival staining
Tear break-up time
Change in artificial tear usage
Patient-reported improvement of foreign body sensation

Secondary Outcome Measures

Name	Time	Method
Visual acuity
Investigator global severity assessment
Patient-reported dry eye symptoms other than foreign body sensation
Biomicroscopy
Ophthalmoscopy
IOP