Condition category
Eye Diseases
Date applied
04/04/2008
Date assigned
17/07/2008
Last edited
17/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

http://www.sophia.com.mx

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

Publication citations

Additional files

Editorial Notes