Efficacy, safety and tolerability assessment of Betafree eye drops in patients with Glaucoma or Ocular Hypertensio

Phase 4

• Conditions: Health Condition 1: null- Patients with Glaucoma and Ocular Hypertension

• Registration Number: CTRI/2018/09/015854
• Lead Sponsor: Micro Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified