Condition category
Eye Diseases
Date applied
04/11/2008
Date assigned
23/12/2008
Last edited
23/12/2008
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 Leopoldo Baiza-Duran

ORCID ID

Contact details

Hidalgo No. 861-A
Colonia Centro
Sector Hidalgo
Guadalajara
44100
Mexico
+52 (01)33 38264152
drbvista@sophia.com.mx

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRTBRII11O6

Study information

Scientific title

Comparative trial of a 0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination versus Cosopt® in open angle glaucoma or ocular hypertension

Acronym

KOEG

Study hypothesis

The hypotensive effect of 0.5% timolol-2% dorzolamide-0.2% brimonidine fixed combination is different from that of Cosopt® in patients with diagnosis of primary open-angle glaucoma (POAG) and/or ocular hypertension with or without pseudoexfoliation.

Ethics approval

Ethics Committee of the Institute of Ophthalmology, Hospital La Carlota (Intituto de Oftalmologia Hospital La Carlota), gave approval on the 27th November 2006

Study design

Phase II double-blind randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Primary open-angle glaucoma, ocular hypertension

Intervention

According to a random chart, 50 patients will receive over each eye one drop of a topical ophthalmic solution composed of timolol 0.5%, dorzolamide 2% and brimonidine 0.2% in a fixed-combination formula developed by Laboratorios Sophia S.A. de C.V. every 12 hours. The other 50 patients will be administered one drop of Cosopt® over each eye every 12 hours. Both medications will be administered during a period of 90 days. All the study articles will be labeled with a non-consecutive code number that is randomly generated by a computer.

Intervention type

Drug

Phase

Phase II

Drug names

Timolol, dorzolamide, brimonidine, Cosopt®

Primary outcome measures

Intraocular pressure. Duration of follow-up: 3 months (90 days).

Secondary outcome measures

1. Visual fields. Duration of follow-up: 3 months (90 days).
2. Ocular surface fluorescein staining. Duration of follow-up: 3 months (90 days).

Overall trial start date

01/01/2007

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must have a clinical diagnosis of mild to moderate primary open-angle glaucoma (POAG) with or without pseudoexfoliation and pigmentary dispersion or ocular hypertension
2. Both males and females, aged 18 years or older
3. Patients with intraocular pressure between 21 and 30 mmHg

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients with one blind eye
2. Patients with visual acuity of 20/40 or worse in either of the two eyes without a justifying cause
3. Patients with a history of any concomitant, active-stage ocular disease except the diseases specified in the inclusion criteria
4. Patients taking any medication, regardless of the route of administration, that decisively interferes with the study results, until 48 hours prior to start of the trial or until a time period in which residual effects could be present
5. Sulfa allergy
6. Patients with history of hypersensibility or any medical situation that contraindicates or makes risky the use of any of the study articles or their compounds under any route of administration as well as any drug or formulation derived from them or related to them
7. Contact lens users
8. Women of childbearing potential who are not using an adequate contraceptive method, as well as pregnant or breast-feeding women
9. Patients with history of cataract surgery with or without intraocular lens (IOL) implant (pseudoaphakia or aphakia) three months or less prior to Day 1 of the trial
10. Patients enrolled in any medical trial out of the Laboratorios Sophia S.A. de C.V. sponsorship within the last 90 days prior to this trial
11. Legally disqualified or mentally disabled patients who cannot sign the informed consent to participate in this trial
12. Patients who cannot comply with the medical appointments or with all the protocol requirements
13. Patients who disagree to participate in this trial
14. Patients with optic disc excavation greater than or equal to 0.8
15. Normal-tension glaucoma patients

Recruitment start date

01/01/2007

Recruitment end date

31/05/2007

Locations

Countries of recruitment

Mexico

Trial participating centre

Hidalgo No. 861-A
Guadalajara
44100
Mexico

Sponsor information

Organisation

Laboratorios Sophia S.A de C.V. (Mexico)

Sponsor details

Hidalgo No. 737
Colonia Centro
Sector Hidalgo
Guadalajara
44100
Mexico
+52 (01)33 38264251
drbvista@sophia.com.mx

Sponsor type

Industry

Website

http://www.sophia.com.mx

Funders

Funder type

Industry

Funder name

Laboratorios Sophia S.A. de C.V. (Mexico)

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