Health Condition 1: null- Patients with Glaucoma and Ocular Hypertension
Conditions
Interventions
Intervention1: Betafree Ophthalmic solution: Participants will be administered with one drop of Brinzolamide brimonidine (Betafree) ophthalmic solution twice a day (at 9 AM and 9 PM), for 12 weeks
Con
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed of unilateral or bilateral primary open angle glaucoma (including open angle glaucoma with pseudo exfoliation or pigment dispersion) or ocular hypertension; 2. Insufficiently controlled IOP despite patient being on IOP lowering medication. 3. IOP >21 mmHg measured as a mean of both eyes at two measurements at least one hour apart; 4. Best corrected visual acuity >20 /100 corresponding to log MAR of 0.7in both eyes; 5. In case of women, postmenopausal ( >12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures; 6. Expected by the investigator that IOP would remain controlled with thenew treatment without optic nerve damage or progression of visua l field loss; 7. Patient is able to understand the requirements of the study and to agree to return for required follow-up visits; 8. Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. 2 Severe central visual field loss. 3. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/100 Snellen equivalent). 4. Chronic, recurrent or severe inflammatory eye disease. 5. Ocular trauma within the preceding 6months. 6. Ocular infection or inflammation within the preceding 3months. 7. Clinically significant or progressive retinal disease. 8. Other ocular pathology 9. lntraocularsurgerywithin the 6 months prior to entry. 10. Ocular laser surgery within the 3 months prior to entry. 11. Any abnormality preventing reliable applanation tonometry. 12. Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study. 13. Recent use of high-dose ( >1 gram daily) salicylate therapy. 14. Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist. 15. Other protocol-specified exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean IOP from baselineTimepoint: Baseline, Week 2, Week 6, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of efficacy and tolerability as evaluated by the Investigator using a 4-point scaleTimepoint: Baseline to end of the study (12 weeks);Safety assessment of Betafree based on the adverse effects as mentioned by the patient and as evaluated by the treating physicianTimepoint: Baseline to end of the study (12 weeks) | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar M
Micro Labs Limited, Bangalore
Outcome results
None listed