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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 15, 2008
Last updated: August 29, 2014
Last verified: August 2014

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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Schirmer scores
  • Corneal staining
  • Conjunctival staining
  • Tear break-up time
  • Change in artificial tear usage
  • Patient-reported improvement of foreign body sensation

Secondary Outcome Measures:
  • Visual acuity
  • Investigator global severity assessment
  • Patient-reported dry eye symptoms other than foreign body sensation
  • Biomicroscopy
  • Ophthalmoscopy
  • IOP

Estimated Enrollment: 150
Study Start Date: January 2000
Study Completion Date: January 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)


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.
  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: NCT00679718

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00679718     History of Changes
Other Study ID Numbers: 03-103
Study First Received: May 15, 2008
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis Sicca
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014