ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 20, 2012
CompletedSeptember 7, 2012
September 1, 2012
Same day
August 14, 2012
September 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs
3 weeks
Study Arms (1)
Single Arm: ATS907
EXPERIMENTALSingle-cohort, dose-escalation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altheos, Inc.lead
Study Sites (1)
Sall Research Medical Center
Artesia, California, 90701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 20, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 7, 2012
Record last verified: 2012-09