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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04098861
Enrollment
40
Registered
2019-09-23
Start date
2019-01-02
Completion date
2020-12-01
Last updated
2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma

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.

Interventions

Latanoprost/Timolol Fixed Combination

Sponsors

Universiti Kebangsaan Malaysia Medical Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy: Intraocular pressure reduction4 weeksIOP reduction with LTFC given once and twice daily in POAG patients

Secondary

MeasureTime frameDescription
Safety: Side effects4 weeksSide effects of LTFC given twice daily in POAG patients

Countries

Malaysia

Contacts

Primary ContactMohd Hairul Nizam Harun, MSc
hairulnizam@ppukm.ukm.edu.my+0391457447

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026