Condition category
Eye Diseases
Date applied
11/10/2005
Date assigned
30/03/2006
Last edited
04/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nathan Congdon

ORCID ID

Contact details

Wilmer 120
600 N. Wolfe Street
Baltimore
21287
United States of America
ncongdon@jhmi.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

INGOTT

Study hypothesis

Surgery will be more effective than medicines in controlling glaucoma in India

Ethics approval

Approved by the Internal Review Boards at the Johns Hopkins University, Baltimore, USA and the Aravind Eye Hospital in India

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Glaucoma

Intervention

Medicine (timolol, latanaprost and brimonidine) versus surgery

Intervention type

Drug

Phase

Not Specified

Drug names

Timolol, latanaprost and brimonidine

Primary outcome measures

1. Intraocular pressure
2. Visual acuity
3. Quality of life

Secondary outcome measures

Cataract grade

Overall trial start date

01/01/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Glaucoma patients over the age of 30 years in India

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant exclusion criteria

1. Previous surgery
2. Intraocular pressure (IOP) >35

Recruitment start date

01/01/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

India

Trial participating centre

Wilmer 120
Baltimore
21287
United States of America

Sponsor information

Organisation

Pfizer Inc. (USA)

Sponsor details

Corporate Headquarters
New York
20001
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Pfizer Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes