A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
ATS907
Eye Diseases+1
+ Glaucoma
+ Glaucoma, Open-Angle
Treatment Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 18 years of age or greater Diagnosis of open angle glaucoma or ocular hypertension in both eyes Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) in each eye (equivalent to 20/200) Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study Exclusion Criteria: Ophthalmic (in either eye): Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Refractive surgery in study eye Cataract surgery and or other intraocular surgery within one month prior to Screening in either eye History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented Contact lens wear during the duration of the study Clinically significant ocular disease (e.g., diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location