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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00680108
First received: May 15, 2008
Last updated: September 18, 2013
Last verified: September 2013

May 15, 2008
September 18, 2013
September 1999
September 1999   (final data collection date for primary outcome measure)
  • Evaluation of adverse events
  • Ocular symptomatology
  • Visual acuity
  • Biomicroscopy
  • Ophthalmoscopy
Same as current
Complete list of historical versions of study NCT00680108 on ClinicalTrials.gov Archive Site
Unanesthetized Schirmer test
Same as current
Not Provided
Not Provided
 
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dry Eye Disease
Drug: diquafosol tetrasodium (INS365) ophthalmic solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 1999
September 1999   (final data collection date for primary outcome measure)

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
Not Provided
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00680108
03-102
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP