Comparative trial of a 0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination versus Combigan-D® in open angle glaucoma or ocular hypertension
| ISRCTN | ISRCTN11060993 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11060993 |
| Secondary identifying numbers | KKVSCD0208FII |
- Submission date
- 09/03/2009
- Registration date
- 17/03/2009
- Last edited
- 17/03/2009
- 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
Scientific
Paseo del Norte No. 5255
Fracc. Guadalajara Technology Park
Zapopan
45010
Mexico
| Phone | +52 (01)33 30014200 |
|---|---|
| drbvista@sophia.com.mx |
Study information
| Study design | Phase III double-blind randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Only available to recruiting centres/participants |
| Scientific title | 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 Combigan-D® in open angle glaucoma or ocular hypertension |
| Study acronym | KOSG |
| Study objectives | The hypotensive effect of 0.5% timolol-2% dorzolamide-0.2% brimonidine fixed combination is different from that of Combigan-D® in patients with diagnosis of primary open-angle glaucoma (POAG) and/or ocular hypertension with or without pseudoexfoliation. |
| Ethics approval(s) | 1. Ethics committee of Fundación Oftalmológica Conde de Valenciana, IAP., approved on the 1st September 2008 (ref: CC-019-2008) 2. Ethics committee of Asociación para Evitar la Ceguera en México, IAP., approved on the 16th July 2008 (ref: 08-36) 3. Ethics committee of Fundación Oftalmólogica Hospital Nuestra Señora de la Luz, approved on the 6th May 2008 4. Ethics committee of Hospital Puerta de Hierro, approved on the 13th June 2009 (ref: 2008/05) 5. Ethics committee of Unidad de Investigación Clínica en Medicina, S.C., approved on the 26th January 2009 (ref: 09-001) |
| 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 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 labelled with a non-consecutive code number that is randomly generated by a computer. The total duration of treatment and the total duration of follow-up for will be 3 months, in both arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination, Combigan-D® |
| Primary outcome measure | Intraocular pressure at 3 months (90 days) |
| Secondary outcome measures | 1. Visual fields at 3 months (90 days) 2. Ocular surface fluorescein staining at 3 months (90 days) |
| Overall study start date | 01/01/2009 |
| Completion date | 01/07/2009 |
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 | 01/01/2009 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Paseo del Norte No. 5255
Zapopan
45010
Mexico
45010
Mexico
Sponsor information
Laboratorios Sophia S.A. de C.V. (Mexico)
Industry
Industry
Paseo del Norte No. 5255
Fracc. Guadalajara Technology Park
Zapopan
45010
Mexico
| Phone | +52 (01)33 30014200 |
|---|---|
| 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 |
