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

NCT04098861 | Unknown Phase 4 FDA Drug

• 1 other identifier: FF-2019-058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Efficacy: Intraocular pressure reduction

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

  4 weeks

Secondary Outcomes (1)

• Safety: Side effects

  4 weeks

Study Arms (2)

once daily group

EXPERIMENTAL

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.

Drug: Latanoprost/Timolol

twice daily group

EXPERIMENTAL

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.

Drug: Latanoprost/Timolol

Interventions

Latanoprost/Timolol DRUG

Latanoprost/Timolol Fixed Combination

once daily group; twice daily group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Central Study Contacts

Mohd Hairul Nizam Harun, MSc

CONTACT

+0391457447; hairulnizam@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: January 2, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

MY (1)