Glaucoma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
Interventions
DRUGPlacebo
One drop in each eye every 12 hours for seven days
DRUGINS117548
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * Have best corrected visual acuity in both eyes of at least +0.5 or better
Exclusion criteria
* Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma * Have a history of any type of intraocular surgery, except for cataract surgery * Have had cataract surgery within three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 15 |
| Rate of discontinuation | 15 |
| Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters | 15 |
| Compliance | 15 |
Outcome results
None listed