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Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma

Primary Purpose

Primary Open Angle Glaucoma

Status

Unknown status

Phase

Phase 4

Locations

Malaysia

Study Type

Interventional

Intervention

Latanoprost/Timolol

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 and above
Able to provide informed consent
Diagnosed as having unilateral or bilateral, mild to moderate POAG
The POAG treated with only two antiglaucoma

Exclusion Criteria:

Advanced POAG
Patient with contraindication for topical use of a-blocker and prostaglandin analogue
Patient with contraindication for systemic use of a-blocker
Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol
History of orbital or ocular trauma.
History of cataract surgery less than 6 months.
History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery
Any active eye infections or corneal ulceration.
Patient with ocular surface disease
Other ocular disease that might interfere with IOP measurements or result
Precious eye i.e patient with only one good eye
Contact lens is not allowed within 1 week before the start of study and during the study

Sites / Locations

Universiti Kebangsaan Malaysia Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

once daily group

twice daily group

Arm Description

Latanoprost/Timolol Fixed Combination (LTFC) will be administered once daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate. For once daily dosing, the eye drops will be instilled at 8am every morning. The IOP will be taken at 9am-12pm on study day.

Latanoprost/Timolol Fixed Combination (LTFC) will be administered twice daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate. For twice dosing, the eye drops will be instilled at 8am and 8pm. The IOP will be taken at 9am-12pm on study day.

Outcomes

Primary Outcome Measures

Efficacy: Intraocular pressure reduction

IOP reduction with LTFC given once and twice daily in POAG patients

Secondary Outcome Measures

Safety: Side effects

Side effects of LTFC given twice daily in POAG patients

Full Information

NCT ID

NCT04098861

First Posted

September 19, 2019

Last Updated

September 19, 2019

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT04098861

Brief Title

Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma

Official Title

Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2, 2019 (Actual)

Primary Completion Date

August 31, 2020 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss. Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control. Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

A single-center, randomized open-labeled, prospective, crossover study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

once daily group

Arm Type

Experimental

Arm Description

Arm Title

twice daily group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Latanoprost/Timolol

Intervention Description

Latanoprost/Timolol Fixed Combination

Primary Outcome Measure Information:

Title

Efficacy: Intraocular pressure reduction

Description

IOP reduction with LTFC given once and twice daily in POAG patients

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Safety: Side effects

Description

Side effects of LTFC given twice daily in POAG patients

Time Frame

4 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

gender identity

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 and above Able to provide informed consent Diagnosed as having unilateral or bilateral, mild to moderate POAG The POAG treated with only two antiglaucoma Exclusion Criteria: Advanced POAG Patient with contraindication for topical use of a-blocker and prostaglandin analogue Patient with contraindication for systemic use of a-blocker Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol History of orbital or ocular trauma. History of cataract surgery less than 6 months. History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery Any active eye infections or corneal ulceration. Patient with ocular surface disease Other ocular disease that might interfere with IOP measurements or result Precious eye i.e patient with only one good eye Contact lens is not allowed within 1 week before the start of study and during the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohd Hairul Nizam Harun, MSc

Phone

+0391457447

hairulnizam@ppukm.ukm.edu.my

Facility Information:

Facility Name

Universiti Kebangsaan Malaysia Medical Centre

City

Cheras

State/Province

Wilayah Persekutuan Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohd Hairul

Phone

192347377

hairulnizam@ppukm.ukm.edu.my

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma

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