A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

Dry Eye Disease Clinical Trial

Official title:

A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680108
• Other study ID #: 03-102
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: August 26, 2015
• Start date: September 1999
• Est. completion date: May 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

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2000
• Est. primary completion date: May 2000
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Best corrected visual acuity 20/40 in each eye

• 2 out 5 specified symptoms

• Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion Criteria:

• Unable to stop concomitant medications

• Have had intraocular surgery in previous 90 days

• Have excluded systemic or ocular disease

• Wear contact lenses and are not willing to remove them

• Have intraocular pressure greater than 22 mg Hg

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

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	Evaluation of adverse events
Primary	Ocular symptomatology
Primary	Visual acuity
Primary	Biomicroscopy
Primary	Ophthalmoscopy
Secondary	Unanesthetized Schirmer test