Dry Eye Disease
Conditions
Brief summary
The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.
Interventions
1-2 drops administered in each eye 4 times a day for 6 weeks
DRUGNon-preserved saline solution (Placebo)
1-2 drops administered in each eye 4 times a day for 6 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to any study procedures being performed. * Have a best corrected visual acuity (BCVAof +0.7 or better. * Have a history of dry eye (keratoconjunctivitis sicca) in both eyes * Have ongoing dry eye disease, in the same qualifying eye or both eyes.
Exclusion criteria
* Have previously had LASIK refractive surgery. * Use of topical ophthalmic medications, preps, gels and lid scrubs during study. * Have had penetrating intraocular surgery in the past 90 days. * Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year. * Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid. * Any serious ocular systemic disease or uncontrolled medical condition. * Exposure to any investigational drug within 30 days of study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fluorescein staining scores of the cornea | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | 6 weeks |
Outcome results
None listed