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A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension

This study has been terminated.
(Study terminated due to corporate decision.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01781962
First received: January 30, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.


Condition Intervention
Open-angle Glaucoma
Ocular Hypertension
Other: No Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.


Secondary Outcome Measures:
  • Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.

  • Number of Study Eyes in Each Step Grade Using Gonioscopic Lens [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.


Enrollment: 206
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
Other: No Treatment
No Treatment was given in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension

Criteria

Inclusion Criteria:

  • Of Chinese descent
  • Open-angle Glaucoma or Ocular Hypertension in each eye

Exclusion Criteria:

  • History of a narrow-angle or angle closure glaucoma
  • Angle abnormalities in either eye
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781962

Locations
China
Beijing, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01781962     History of Changes
Other Study ID Numbers: 192024-077
Study First Received: January 30, 2013
Results First Received: June 16, 2014
Last Updated: July 30, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014