ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
NCT ID: NCT01668524
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2012-08-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm: ATS907
Single-cohort, dose-escalation
ATS907
Single dose of each of three increasing concentrations
Interventions
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ATS907
Single dose of each of three increasing concentrations
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Altheos, Inc.
INDUSTRY
Responsible Party
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Locations
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Sall Research Medical Center
Artesia, California, United States
Countries
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Other Identifiers
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ATS907-205
Identifier Type: -
Identifier Source: org_study_id