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Trial record 67 of 8393 for:    Ophthalmopathy

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

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: NCT00679718
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:
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2000
Actual Primary Completion Date : July 2000
Actual Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Primary Outcome Measures :
  1. Schirmer scores
  2. Corneal staining
  3. Conjunctival staining
  4. Tear break-up time
  5. Change in artificial tear usage
  6. Patient-reported improvement of foreign body sensation

Secondary Outcome Measures :
  1. Visual acuity
  2. Investigator global severity assessment
  3. Patient-reported dry eye symptoms other than foreign body sensation
  4. Biomicroscopy
  5. Ophthalmoscopy
  6. IOP

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

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.

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): NCT00679718

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

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00679718     History of Changes
Other Study ID Numbers: 03-103
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

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