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Clinical Trials/CTRI/2018/09/015854
CTRI/2018/09/015854
Recruiting
Phase 4

An observational study on the efficacy, safety, and tolerability of Betafree (Brinzolamide 1% and Brimonidine 0.2%) ophthalmic suspension in the management of Primary Angle Glaucoma / Ocular Hypertension - BRIGHT STUDY

Micro Labs Limited0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Micro Labs Limited
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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