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

Dry Eye Disease Clinical Trial

Official title:

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679718
• Other study ID #: 03-103
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: August 26, 2015
• Start date: January 2000
• Est. completion date: July 2000

Study information

• Verified date: August 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2000
• Est. primary completion date: July 2000
• Gender: Both
• Age group: N/A and older

Eligibility

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

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• diquafosol tetrasodium (INS365) ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer scores
Primary	Corneal staining
Primary	Conjunctival staining
Primary	Tear break-up time
Primary	Change in artificial tear usage
Primary	Patient-reported improvement of foreign body sensation
Secondary	Visual acuity
Secondary	Investigator global severity assessment
Secondary	Patient-reported dry eye symptoms other than foreign body sensation
Secondary	Biomicroscopy
Secondary	Ophthalmoscopy
Secondary	IOP