Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

NCT01779284 | Completed Phase 4

• 1 other identifier: A23
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Keywords

glaucoma; fixed combinations; 24-hour monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• rate of adverse events with the two medications

  3 months

• ocular surface indicators after 3 months of therapy with the two medications

  3 months

Study Arms (2)

Travoprost/Timolol therapy

ACTIVE COMPARATOR

Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Drug: Travoprost/timolol therapy; Drug: Latanoprost/Timolol therapy

Latanoprost/Timolol therapy

ACTIVE COMPARATOR

Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Drug: Travoprost/timolol therapy; Drug: Latanoprost/Timolol therapy

Interventions

Travoprost/timolol therapy DRUG

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Also known as: DuoTrav BAK Free

Latanoprost/Timolol therapy; Travoprost/Timolol therapy

Latanoprost/Timolol therapy DRUG

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Also known as: Xalacom

Latanoprost/Timolol therapy; Travoprost/Timolol therapy

Eligibility Criteria

• Age: 29 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, 546 36, Greece

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Travoprost; Latanoprost; Xalacom

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

GR (1)