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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098861
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Norshamsiah Md Din, Universiti Kebangsaan Malaysia Medical Centre

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.


Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Drug: Latanoprost/Timolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A single-center, randomized open-labeled, prospective, crossover study.
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.

Drug: Latanoprost/Timolol
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.

Drug: Latanoprost/Timolol
Latanoprost/Timolol Fixed Combination




Primary Outcome Measures :
  1. Efficacy: Intraocular pressure reduction [ Time Frame: 4 weeks ]
    IOP reduction with LTFC given once and twice daily in POAG patients


Secondary Outcome Measures :
  1. Safety: Side effects [ Time Frame: 4 weeks ]
    Side effects of LTFC given twice daily in POAG patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   gender identity
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098861


Contacts
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Contact: Mohd Hairul Nizam Harun, MSc +0391457447 hairulnizam@ppukm.ukm.edu.my

Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre Recruiting
Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
Contact: Mohd Hairul    192347377    hairulnizam@ppukm.ukm.edu.my   
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
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Responsible Party: Norshamsiah Md Din, Associate Professor, Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT04098861    
Other Study ID Numbers: FF-2019-058
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Latanoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents