Primary open angle glaucoma Eye Diseases Glaucoma
Conditions
Interventions
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 fo
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.
Sponsors
Laboratorios Sophia S.A. de C.V. (Mexico)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure, measured at days 0, 7, 15, 30, 60 and 90. In all days the measurement will be at 8:00 am. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual fields, evaluation at at days 0 and 90 2. Ocular surface fluorescein staining, measured at at days 0 and 90 | — |
Countries
Bolivia, Chile, Colombia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru, Venezuela
Outcome results
None listed