Dry Eye Disease
Conditions
Brief summary
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.
Interventions
One to two drops in each eye QID for 6 weeks
DRUGPlacebo
One to two drops in each eye QID 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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) | 6 weeks |
Outcome results
None listed