Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma
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|ClinicalTrials.gov Identifier: NCT04098861|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Open Angle Glaucoma||Drug: Latanoprost/Timolol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A single-center, randomized open-labeled, prospective, crossover study.|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma|
|Actual Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||December 1, 2020|
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.
Latanoprost/Timolol Fixed Combination
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.
Latanoprost/Timolol Fixed Combination
- Efficacy: Intraocular pressure reduction [ Time Frame: 4 weeks ]IOP reduction with LTFC given once and twice daily in POAG patients
- Safety: Side effects [ Time Frame: 4 weeks ]Side effects of LTFC given twice daily in POAG patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098861
|Contact: Mohd Hairul Nizam Harun, MScfirstname.lastname@example.org|
|Universiti Kebangsaan Malaysia Medical Centre||Recruiting|
|Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000|
|Contact: Mohd Hairul 192347377 email@example.com|