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 hypertensio
- Conditions
- Primary open-angle glaucoma, ocular hypertensionEye DiseasesGlaucoma
- Registration Number
- ISRCTN11060993
- Lead Sponsor
- aboratorios Sophia S.A. de C.V. (Mexico)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraocular pressure at 3 months (90 days)
- Secondary Outcome Measures
Name Time Method 1. Visual fields at 3 months (90 days)<br>2. Ocular surface fluorescein staining at 3 months (90 days)