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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 15, 2008
Last updated: August 26, 2015
Last verified: August 2015
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
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: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00680108

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Clinical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00680108     History of Changes
Other Study ID Numbers: 03-102
Study First Received: May 15, 2008
Last Updated: August 26, 2015

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions processed this record on September 19, 2017