Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Glaucoma Clinical Trial

Official title:

24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779284
• Other study ID #: A23
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2013
• Last updated: May 9, 2014
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 80 Years

Eligibility

Inclusion Criteria:

• Primary open-angle glaucoma or exfoliative glaucoma

• Patients who require additional IOP lowering on latanoprost monotherapy

• Morning IOP greater than 20 mm Hg on latanoprost monotherapy

• Untreated morning IOP greater than 26 mm Hg

• Patients older than 29 years

• Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)

• On therapy with latanoprost monotherapy for at least 3 months

• Patients with a reliable visual field

• Best corrected distance Snellen visual acuity >1/10

• Corneal pachymetry within the 550 ± 50 µm range

• Patients should understand the study instructions

• Patients willing to attend all follow-up appointments and willing to comply with study medication usage

• Patients who have open, normal appearing angles

Exclusion Criteria:

• History of combined topical therapy

• Contraindication to prostaglandins or timolol

• History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses

• Sign of ocular infection except for mild blepharitis

• Any corneal abnormality that could have affected the measurement of IOP

• Chronic use of topical corticosteroids in the last 3 months before entering the study

• Current, or previous use of systemic corticosteroid treatment

• Uncontrolled systemic disease

• Change of a systemic medication during the study period

• Women of childbearing potential or lactating mothers

• Inability to understand the instructions and adhere to medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Travoprost/timolol therapy
Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
• Latanoprost/Timolol therapy
Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour intraocular pressure reduction between the two medications	Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer	3 months	No
Secondary	rate of adverse events with the two medications	At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health.	3 months	Yes
Secondary	ocular surface indicators after 3 months of therapy with the two medications	Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications.	3 months	Yes