Efficacy and Safety of Latanoprost/Timolol for Primary Open Angle Glaucoma
NCT ID: NCT04098861
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2019-01-02
2020-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
Latanoprost/Timolol Fixed Combination
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
Latanoprost/Timolol Fixed Combination
Interventions
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Latanoprost/Timolol
Latanoprost/Timolol Fixed Combination
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Universiti Kebangsaan Malaysia Medical Centre
OTHER
Responsible Party
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Norshamsiah Md Din
Associate Professor
Locations
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Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FF-2019-058
Identifier Type: -
Identifier Source: org_study_id
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