Safety and efficacy on glaucoma treatment with 3 topical medicationsin one bottle x medications in separated bottles
- Conditions
- open angle glaucoma
- Registration Number
- RBR-6kkmskk
- Lead Sponsor
- centro oftalmologico de minas gerais
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
18 years of age minimum; ocular hypertension with intraocular pressure levels greater than or equal to 21 mmHg; carrier of open angle glaucoma presenting intraocular pressure levels greater than or equal to 18 mmHg; reduction of intraocular pressure in relation to baseline values ??<30%; patients intolerant of current treatment due to ocular surface symptoms; meet the criteria of the control group for at least 3 months;
monoaminoxidase users; patients with asthma or severe chronic obstructive pulmonary disease; patients with sinus bradycardia, atrioventricular block of 2 or 3 degrees not controlled with a pacemaker, decompensated congestive heart failure; patient known to be allergic to any of the components of TRIPLENEX; pregnant patients; patients with any corneal irregularity that hinder the perfect reading of intraocular pressure by Goldman's tonometer (intra stromal ring, corneal transplant or scars with important corneal thinning); patients undergoing anti-glaucoma surgical procedures in the last 3 months (laser trabeculoplasty; incisional procedures such as trabeculectomy; glaucoma drainage devices, among others)
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate IOP reduction in TRIPLENEX group when compared to control group through t student test ( comparing the mean between groups). We decided to use significance level of 0,05% and 90 % of power. IOP values more than 2.52 mmHg between groups will be considered statistical significance taking into account a calculated effect of 85 % for the study
- Secondary Outcome Measures
Name Time Method Evaluate whether with the use of TRIPLENEX there is a change in the symptoms of ocular surface disease through the application of the OSDI questionnaire (ocular surface disease index)