To study the effect and safety of Forskolin eye drops 1% in patients suffering from Open angle Glaucoma
Phase 3
Completed
- Conditions
- Health Condition 1: null- Adult male or female subjects with primary open angle glaucoma
- Registration Number
- CTRI/2013/12/004188
- Lead Sponsor
- Sami labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1 Adult patients male or female having open angle glaucoma will be included in the study
2 Glaucoma with intra ocular pressure of more than 24 mm/Hg will be included.
3 No miotic or other therapy 24 hours before
4 off systemic therapy for glaucoma for at least 4 days
5 Informed consent given
Exclusion Criteria
1 Inflammatory ophthalmic dose during the last 3 months
2 Secondary or closed angle glaucoma
3 Bronchial asthma
4 Chronic obstructive pulmonary disease
5 Uncompensated cardiac failure
6 Sinus bradycardia
7 2nd or 3rd degree AV Block
8 Concurrent drug intake for eg β blockers diamox etc
9 Pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Forskolin eye drops 1%Timepoint: Reduction in Intra ocular pressure as compared to Baseline. Tonometric readings will be recorded at 0.5,1,2,3,4,5 and 6 hours.
- Secondary Outcome Measures
Name Time Method Safety of Forskolin eye drops 1%Timepoint: Adverse Events will be assessed at all visits - Day 1, Day 7, Day 14, Day 21 and Day 28.