Comparative clinical trial of Krytantek Ofteno® versus Combigan D® in patients with primary open-angle glaucoma

ISRCTN	ISRCTN48477221
DOI	https://doi.org/10.1186/ISRCTN48477221
Secondary identifying numbers	KKVSCD0208FII

Submission date: 04/04/2008
Registration date: 17/07/2008
Last edited: 17/07/2008

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 3826 4152
Email	drbvista@sophia.com.mx

Study information

Study design	Multicentre, prospective, longitudinal, comparative, double-blind clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact drbvista@sophia.com.mx to request a patient information sheet
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
Study acronym	KOEG
Study objectives	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(s)	Ethics approval received from the local ethics committee (Nuestra Señora de la Luz Hospital, Mexico City) on the 20th June 2008.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Krytantek Ofteno®, Combigan D®
Primary outcome measure	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 study start date	30/04/2008
Completion date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	88 patients
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. 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
Key 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
Date of first enrolment	30/04/2008
Date of final enrolment	30/04/2009

Locations

Countries of recruitment

Bolivia
Chile
Colombia
Dominican Republic
Ecuador
El Salvador
Guatemala
Honduras
Mexico
Nicaragua
Panama
Peru
Venezuela

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 3826 4251
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