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

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ClinicalTrials.gov Identifier: NCT00680108
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : August 27, 2015
Sponsor:
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

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Ages Eligible for Study:   Child, Adult, Senior
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00680108


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov 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
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions