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 Cosopt® in open angle glaucoma or ocular hypertension

ISRCTN	ISRCTN26988657
DOI	https://doi.org/10.1186/ISRCTN26988657
Secondary identifying numbers	DRTBRII11O6

Submission date: 04/11/2008
Registration date: 23/12/2008
Last edited: 23/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Leopoldo Baiza-Duran
Scientific

Hidalgo No. 861-A
Colonia Centro
Sector Hidalgo
Guadalajara
44100
Mexico

Phone	+52 (01)33 38264152
Email	drbvista@sophia.com.mx

Study information

Study design	Phase II double-blind randomised controlled multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Study acronym	KOEG
Study objectives	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(s)	Ethics Committee of the Institute of Ophthalmology, Hospital La Carlota (Intituto de Oftalmologia Hospital La Carlota), gave approval on the 27th November 2006
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Timolol, dorzolamide, brimonidine, Cosopt®
Primary outcome measure	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 study start date	01/01/2007
Completion date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/05/2007

Locations

Countries of recruitment

Mexico

Study participating centre

Hidalgo No. 861-A

Guadalajara
44100
Mexico

Sponsor information

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

Hidalgo No. 737
Colonia Centro
Sector Hidalgo
Guadalajara
44100
Mexico

Phone	+52 (01)33 38264251
Email	drbvista@sophia.com.mx
Website	http://www.sophia.com.mx
"ROR"	https://ror.org/00zpf2822

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan