The Effectiveness of Topical Latanoprost Compared With To... | NCT04205201

Studies
The Effectiveness of Topical Latanoprost Compared With Topical Brimonidine in the Treatment of the Primary Open Angle Glaucoma

NCT04205201

Sponsor

Chittagong Medical College

Status

Completed

Last Update Posted

Dec 26, 2019Actual

Enrollment

80Actual

Phase

Phase 2

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

Interventions

Drugs, Investigational

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2018Actual

Primary Completion Date

Sep 24, 2019Actual

Completion Date

Oct 5, 2019Actual

First Submitted Date

Dec 17, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2019

Last Update Posted Date

Dec 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Latanoprost	Drug: Drugs, Investigational
Group B	Other	Brimonidine	Drug: Drugs, Investigational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drugs, Investigational	Drug	To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
More than 20% IOP reduction	From baseline to month 3	0_3 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse reaction	Record every follow up period baseline to month 3.	O_3 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

18_90years

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Facuity of basic science and para clinical science		Dhaka	Chittagong		Bangladesh
Facuity of basic scienceand para clinican science

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D004364	Pharmaceutical Preparations
D011810	Quinoxalines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds