Primary open-angle glaucoma, ocular hypertension Eye Diseases Glaucoma
Conditions
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. Both males and females, aged 18 years or older 3. Patients with intraocular pressure between 21 and 30 mmHg
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure at 3 months (90 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual fields at 3 months (90 days) 2. Ocular surface fluorescein staining at 3 months (90 days) | — |
Countries
Mexico
Outcome results
None listed