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
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