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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00679718
First received: May 15, 2008
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Opthahlmic Solution vs. Placebo in Patients With Moderate to Severe Dry Eye Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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)
  Eligibility

Criteria

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 contanct lens and refuse to remove them
  • Have other excluded eye conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679718

Sponsors and Collaborators
Merck
Investigators
Study Director: Amy Schaberg, BSN Merck
  More Information

No publications provided

Responsible Party: Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00679718     History of Changes
Other Study ID Numbers: 03-103
Study First Received: May 15, 2008
Last Updated: June 7, 2011
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 May 19, 2013