NCT01781962

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 31, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

January 30, 2013

Results QC Date

June 16, 2014

Last Update Submit

July 30, 2014

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)

    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.

    Day 1

Secondary Outcomes (2)

  • Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens

    Day 1

  • Number of Study Eyes in Each Step Grade Using Gonioscopic Lens

    Day 1

Study Arms (1)

All Participants

Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.

Other: No Treatment

Interventions

No TreatmentOTHER

No Treatment was given in this study.

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • History of a narrow-angle or angle closure glaucoma
  • Angle abnormalities in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 1, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 31, 2014

Results First Posted

July 31, 2014

Record last verified: 2014-07

Locations

CN(1)