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 3826 4152
drbvista@sophia.com.mx
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KKVSCD0208FII
Study information
Scientific title
Comparative clinical trial of the safety and efficacy of Krytantek Ofteno® formulated by Laboratorios Sophia S.A. de C.V. versus Combigan D® in the treatment of patients with primary open-angle glaucoma or ocular hypertension
Acronym
KOEG
Study hypothesis
There is no difference between the hypotensive effect of Krytantek Ofteno® versus Combigan D® in patients with a diagnosis of primary open-angle glaucoma (POAG) and/or ocular hypertension with or without pseudoexfoliation.
Ethics approval
Ethics approval received from the local ethics committee (Nuestra Señora de la Luz Hospital, Mexico City) on the 20th June 2008.
Study design
Multicentre, prospective, longitudinal, comparative, double-blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact drbvista@sophia.com.mx to request a patient information sheet
Condition
Primary open angle glaucoma
Intervention
According to the random chart, 44 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 (Krytantek Ofteno®) developed by Laboratorios Sophia S.A. de C.V. each 12 hours. The other 44 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 labeled with a non-consecutive "code number" that is randomly-generated by computer.
Intervention type
Drug
Phase
Not Specified
Drug names
Krytantek Ofteno®, Combigan D®
Primary outcome measures
Intraocular pressure, measured at days 0, 7, 15, 30, 60 and 90. In all days the measurement will be at 8:00 am.
Secondary outcome measures
1. Visual fields, evaluation at at days 0 and 90
2. Ocular surface fluorescein staining, measured at at days 0 and 90
Overall trial start date
30/04/2008
Overall trial end date
30/04/2009
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. Patients may be of both masculine or feminine genders and must be 18 years old or older
3. Patients with intraocular pressure between 21 - 30 mmHg
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
88 patients
Participant exclusion criteria
1. Patients with one blind eye
2. Patients with visual acuity of 20/40 or worst in any of both eyes without a justifying cause
3. Patients with active stage history of any concomitant ocular disease besides the required one
4. Patients taking any medication, whether topically or by any route of administration, that decisively interferes in the study's results, until 48 hours previous to the day 1 of the trial or until a time period in which residual effects could be present
5. Sulfa allergy patients
6. Patients with history of hypersensibility or any medical situation that contraindicates or makes the using of risky for 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 lenses users
8. Fertile-age women 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 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 under 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 clinical trial
12. Patients who cannot comply with the medical appointments or with all the protocol requirements
13. Patients who refuse to participate in this clinical trial
14. Patients with optic disc excavation equal to 0.8 or more
15. Normal-tension glaucoma patients
Recruitment start date
30/04/2008
Recruitment end date
30/04/2009
Locations
Countries of recruitment
Bolivia, Chile, Colombia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru, Venezuela
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 3826 4251
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