The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00831662
First received: January 27, 2009
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.
Condition | Intervention | Phase |
---|---|---|
Dry Eye Disease |
Drug: Diquafosol tetrasodium ophthalmic solution, 2% Drug: Placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Enrollment: | 490 |
Study Start Date: | January 2009 |
Study Completion Date: | January 2010 |
Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Arm 2 |
Drug: Placebo
One to two drops in each eye QID for 6 weeks
|
Experimental: Arm 1 |
Drug: Diquafosol tetrasodium ophthalmic solution, 2%
One to two drops in each eye QID for 6 weeks
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have best corrected visual acuity in both eyes of at least +0.7 or better
- Central corneal staining of 3 on the NEI scale
- If female, are non-pregnant or non-lactating
- Have a history of dry eye disease in both eyes
- Have normal lid anatomy
Exclusion Criteria:
- Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
- Have had ocular surface surgery within the past year
- Are considered legally blind in one eye
- Have a serious medical condition which could confound study assessments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831662
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Show 47 Study Locations
Sponsors and Collaborators
Merck
Investigators
Study Director: | Reza Haque, MD, PhD | Medical Monitor, Inspire |
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
No publications provided
Responsible Party: | Saiid Davari, Inspire |
ClinicalTrials.gov Identifier: | NCT00831662 History of Changes |
Other Study ID Numbers: | 03-113, P08637 |
Study First Received: | January 27, 2009 |
Last Updated: | September 20, 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 October 18, 2012