The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Primary Purpose
To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Drugs, Investigational
Sponsored by
About this trial
This is an interventional basic science trial for To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
Eligibility Criteria
Inclusion Criteria:
- IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.
Exclusion Criteria:
- pregnant and lactating women, infection, any eye surgery.
Sites / Locations
- Facuity of basic science and para clinical science
- Facuity of basic scienceand para clinican science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
Latanoprost
Brimonidine
Outcomes
Primary Outcome Measures
More than 20% IOP reduction
From baseline to month 3
Secondary Outcome Measures
Adverse reaction
Record every follow up period baseline to month 3.
Full Information
NCT ID
NCT04205201
First Posted
December 17, 2019
Last Updated
December 22, 2019
Sponsor
Chittagong Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04205201
Brief Title
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Official Title
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
September 24, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chittagong Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Generated by pharmaceutical companies.
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Latanoprost
Arm Title
Group B
Arm Type
Other
Arm Description
Brimonidine
Intervention Type
Drug
Intervention Name(s)
Drugs, Investigational
Other Intervention Name(s)
Brimonidine
Intervention Description
To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
Primary Outcome Measure Information:
Title
More than 20% IOP reduction
Description
From baseline to month 3
Time Frame
0_3 months
Secondary Outcome Measure Information:
Title
Adverse reaction
Description
Record every follow up period baseline to month 3.
Time Frame
O_3 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18_90years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.
Exclusion Criteria:
pregnant and lactating women, infection, any eye surgery.
Facility Information:
Facility Name
Facuity of basic science and para clinical science
City
Dhaka
State/Province
Chittagong
Country
Bangladesh
Facility Name
Facuity of basic scienceand para clinican science
City
Chittagong
State/Province
Chokhbazar
Country
Bangladesh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
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