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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00680108
First received: May 15, 2008
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Dry Eye Disease
Drug: diquafosol tetrasodium (INS365) ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Evaluation of adverse events
  • Ocular symptomatology
  • Visual acuity
  • Biomicroscopy
  • Ophthalmoscopy

Secondary Outcome Measures:
  • Unanesthetized Schirmer test

Estimated Enrollment: 62
Study Start Date: September 1999
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
  Eligibility

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680108

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00680108     History of Changes
Other Study ID Numbers: 03-102
Study First Received: May 15, 2008
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on April 23, 2014