ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Altheos, Inc.
ClinicalTrials.gov Identifier:
NCT01668524
First received: August 14, 2012
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: ATS907
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Altheos, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm: ATS907
Single-cohort, dose-escalation
Drug: ATS907
Single dose of each of three increasing concentrations

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01668524

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
Sponsors and Collaborators
Altheos, Inc.
  More Information

No publications provided

Responsible Party: Altheos, Inc.
ClinicalTrials.gov Identifier: NCT01668524     History of Changes
Other Study ID Numbers: ATS907-205
Study First Received: August 14, 2012
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014