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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680108
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
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.
Study Start Date : September 1999
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluation of adverse events
  2. Ocular symptomatology
  3. Visual acuity
  4. Biomicroscopy
  5. Ophthalmoscopy

Secondary Outcome Measures :
  1. Unanesthetized Schirmer test

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680108

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00680108     History of Changes
Other Study ID Numbers: 03-102
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions