Open-angle Glaucoma or Ocular Hypertension
Conditions
Keywords
Santen, Eye, Glaucoma, Ocular hypertension
Brief summary
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
Detailed description
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
Interventions
Sponsors
Santen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes * Qualifying intraocular pressure in at least one eye at Baseline * Qualifying corrected ETDRS visual acuity in each eye * Qualifying central cornea thickness in each eye Main
Exclusion criteria
* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye * Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy * Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria * History of ocular surgery specifically intended to lower IOP * History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study * Intended or current use of any ocular medications other than study medications during the study * Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment * Known allergy or sensitivity to any components of the study medications * Use of steroids (systemic) within 30 days prior to Visit 1 (Screening) * Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period * Females who are pregnant, nursing or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (mmHg) | Day 1, Day 8, Day 15 and Day 29 | Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 1, Day 8, Day 15 and Day 29 | Adverse events will be assessed at each visit to evaluate safety |
| Ocular signs and symptoms | Day 1, Day 8, Day 15 and Day 29 | Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry |
Countries
United States
Outcome results
None listed