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

Overview

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.

Full Title of Study: “Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

Interventions

  • Drug: Latanoprost/Timolol
    • Latanoprost/Timolol Fixed Combination

Arms, Groups and Cohorts

  • Experimental: once daily group
    • 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.
  • Experimental: twice daily group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy: Intraocular pressure reduction
    • Time Frame: 4 weeks
    • IOP reduction with LTFC given once and twice daily in POAG patients

Secondary Measures

  • Safety: Side effects
    • Time Frame: 4 weeks
    • Side effects of LTFC given twice daily in POAG patients

Participating in This Clinical Trial

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

Gender Eligibility: All

gender identity

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universiti Kebangsaan Malaysia Medical Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Norshamsiah Md Din, Associate Professor – Universiti Kebangsaan Malaysia Medical Centre
  • Overall Contact(s)
    • Mohd Hairul Nizam Harun, MSc, +0391457447, hairulnizam@ppukm.ukm.edu.my

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