ISRCTN - ISRCTN11060993: Comparative trial of a 0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination versus Combigan-D® in open angle glaucoma or ocular hypertension

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

Paseo del Norte No. 5255
Fracc. Guadalajara Technology Park
Zapopan
45010
Mexico
+52 (01)33 30014200
drbvista@sophia.com.mx

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KKVSCD0208FII

Study information

Scientific title

Multicentre comparative clinical trial of the safety and efficacy of a 0.5% timolol-2% dorzolamide-0.2% brimonidine ophthalmic solution in fixed combination (formulated by Laboratorios Sophia S.A. de C.V.) versus Combigan-D® in open angle glaucoma or ocular hypertension

Acronym

KOSG

Study hypothesis

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

Ethics approval

1. Ethics committee of Fundación Oftalmológica Conde de Valenciana, IAP., approved on the 1st September 2008 (ref: CC-019-2008)
2. Ethics committee of Asociación para Evitar la Ceguera en México, IAP., approved on the 16th July 2008 (ref: 08-36)
3. Ethics committee of Fundación Oftalmólogica Hospital Nuestra Señora de la Luz, approved on the 6th May 2008
4. Ethics committee of Hospital Puerta de Hierro, approved on the 13th June 2009 (ref: 2008/05)
5. Ethics committee of Unidad de Investigación Clínica en Medicina, S.C., approved on the 26th January 2009 (ref: 09-001)

Study design

Phase III 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

Only available to recruiting centres/participants

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 Combigan-D® over each eye every 12 hours. Both medications will be administered during a period of 90 days. All the study articles will be labelled with a non-consecutive code number that is randomly generated by a computer.

The total duration of treatment and the total duration of follow-up for will be 3 months, in both arms.

Intervention type

Drug

Phase

Phase III

Drug names

0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination, Combigan-D®

Primary outcome measure

Intraocular pressure at 3 months (90 days)

Secondary outcome measures

1. Visual fields at 3 months (90 days)
2. Ocular surface fluorescein staining at 3 months (90 days)

Overall trial start date

01/01/2009

Overall trial end date

01/07/2009

Reason abandoned (if study stopped)

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

01/01/2009

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Mexico

Trial participating centre

Paseo del Norte No. 5255
Zapopan
45010
Mexico

Sponsor information

Organisation

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

Sponsor details