- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205201
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma
December 22, 2019 updated by: Abul Khayer, Chittagong Medical College
Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chittagong
-
Dhaka, Chittagong, Bangladesh
- Facuity of basic science and para clinical science
-
-
Chokhbazar
-
Chittagong, Chokhbazar, Bangladesh
- Facuity of basic scienceand para clinican science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IOP 22_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.
Exclusion Criteria:
- pregnant and lactating women, infection, any eye surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Latanoprost
|
To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
Other Names:
|
|
Other: Group B
Brimonidine
|
To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
More than 20% IOP reduction
Time Frame: 0_3 months
|
From baseline to month 3
|
0_3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse reaction
Time Frame: O_3 months
|
Record every follow up period baseline to month 3.
|
O_3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2018
Primary Completion (Actual)
September 24, 2019
Study Completion (Actual)
October 5, 2019
Study Registration Dates
First Submitted
December 17, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
December 26, 2019
Last Update Submitted That Met QC Criteria
December 22, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Glaucoma, Open-Angle
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Brimonidine Tartrate
Other Study ID Numbers
- CMC/PG/2018/1828
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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