Open-angle Glaucoma or Ocular Hypertension Clinical Trial
Official title:
A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Verified date | April 2018 |
Source | Santen Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
Status | Completed |
Enrollment | 91 |
Est. completion date | September 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Santen Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure (mmHg) | Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry | Day 1, Day 8, Day 15 and Day 29 | |
Secondary | Adverse events | Adverse events will be assessed at each visit to evaluate safety | Day 1, Day 8, Day 15 and Day 29 | |
Secondary | Ocular signs and symptoms | 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 | Day 1, Day 8, Day 15 and Day 29 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04133311 -
A Phase III Multinational Multicenter Investigator-Masked Randomized Active-Controlled Trial Comparing the Efficacy and Safety of DE-130A With Xalatan® in Patients With Open-Angle Glaucoma or Ocular Hypertension
|
Phase 3 |