Open-angle GlaucomaNCT01781962

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

An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: No Treatment
How many people: 206 participants
Where: 1 siteChina
Study dates: Jan 2013to Jun 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Beijing

Other trials in China

About this study

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

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: No Treatment
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No TreatmentOther
No Treatment was given in this study.

Study groups in NCT01781962
Study group	Role	What they receive
All Participants		Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients. Receives: Other: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1

Secondary outcomes (2)

Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
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.
Measured: Day 1
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jun 2013

First posted1 Feb 2013 (estimated)
Study startJan 2013
Primary completionJun 2013
Study completionJun 2013

Why it stopped: Study terminated due to corporate decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01781962
Sponsor's protocol ID: 192024-077
Status last verified: Jul 2014
First submitted: 30 Jan 2013
Last updated: 31 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Open-angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension
ClinicalTrials.gov ID: NCT01781962
Acronym / sponsor ID: 192024-077
Conditions: Open-angle Glaucoma, Ocular Hypertension
Study type: Observational
Recruitment status: TerminatedReason stopped: Study terminated due to corporate decision.
Enrolment: 206 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 1 Feb 2013 (estimated)
Results: Posted 31 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Participants	–	Other: No TreatmentOpen-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No TreatmentNo Treatment was given in this study.	Other	All Participants

Primary outcome

Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)
Time frame: Day 1
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.

2 secondary outcomes

Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens
Time frame: Day 1
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens
Time frame: Day 1

Results and safety

Results posted to the registry on 31 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	206	201

Primary outcome: Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)

Time frame: Day 1. Mean (Standard Deviation). Unit: µm

Measure	All Participants n = 179
Value	638.8 (272.67)

Population analysed: Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from Screening through Day 1 (Up to 5 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 206 (0%)	0 of 206 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01781962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.