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

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04098861
• Other study ID #: FF-2019-058
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Mohd Hairul Nizam Harun, MSc
• Phone: +0391457447
• Email: hairulnizam[@]ppukm.ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 and above

2. Able to provide informed consent

3. Diagnosed as having unilateral or bilateral, mild to moderate POAG

4. The POAG treated with only two antiglaucoma

Exclusion Criteria:

1. Advanced POAG

2. Patient with contraindication for topical use of a-blocker and prostaglandin analogue

3. Patient with contraindication for systemic use of a-blocker

4. Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol

5. History of orbital or ocular trauma.

6. History of cataract surgery less than 6 months.

7. History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery

8. Any active eye infections or corneal ulceration.

9. Patient with ocular surface disease

10. Other ocular disease that might interfere with IOP measurements or result

11. Precious eye i.e patient with only one good eye

12. Contact lens is not allowed within 1 week before the start of study and during the study

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Drug:
• Latanoprost/Timolol
Latanoprost/Timolol Fixed Combination

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Cheras	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Intraocular pressure reduction	IOP reduction with LTFC given once and twice daily in POAG patients	4 weeks
Secondary	Safety: Side effects	Side effects of LTFC given twice daily in POAG patients	4 weeks