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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

August 14, 2012
September 5, 2012
August 2012
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01668524 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
Drug: ATS907
Single dose of each of three increasing concentrations
Experimental: Single Arm: ATS907
Single-cohort, dose-escalation
Intervention: Drug: ATS907
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01668524
ATS907-205
No
Altheos, Inc.
Altheos, Inc.
Not Provided
Not Provided
Altheos, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP