NCT04205201

Brief Summary

Outpatient department of cmch, ceitc,cimch POAG patients enrolled for the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 17, 2019

Last Update Submit

December 22, 2019

Conditions

To See the Safety and Efficacy of the Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma Patients

Outcome Measures

Primary Outcomes (1)

  • More than 20% IOP reduction

    From baseline to month 3

    0_3 months

Secondary Outcomes (1)

  • Adverse reaction

    O_3 months

Study Arms (2)

Group A

EXPERIMENTAL

Latanoprost

Drug: Drugs, Investigational

Group B

OTHER

Brimonidine

Drug: Drugs, Investigational

Interventions

Drugs, InvestigationalDRUG

To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle

Also known as: Brimonidine
Group AGroup B

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18\_90years
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IOP 22\_34mmof Hg,newly diagnosed case, bilateral POAG patients Patients.

You may not qualify if:

  • pregnant and lactating women, infection, any eye surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Facuity of basic science and para clinical science

Dhaka, Chittagong, Bangladesh

Location

Facuity of basic scienceand para clinican science

Chittagong, Chokhbazar, Bangladesh

Location

MeSH Terms

Interventions

Drugs, InvestigationalBrimonidine Tartrate

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Generated by pharmaceutical companies.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

June 25, 2018

Primary Completion

September 24, 2019

Study Completion

October 5, 2019

Last Updated

December 26, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

BA(2)