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Efficacy of Travoprost/Timolol for Uncontrolled Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT02003391
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Beta-blocker monotherapy Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: DuoTrav
Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks.
Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Other Name: DUOTRAV®

Active Comparator: Beta-blocker
Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks.
Drug: Beta-blocker monotherapy
Per participant's current prescribed therapy

Drug: Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution
Other Name: DUOTRAV®




Primary Outcome Measures :
  1. Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye [ Time Frame: Week 4 ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.

  2. Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.
  • Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction.
  • Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.
  • Must be able to understand and sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Use of medication excluded by the protocol.
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol.
  • Ocular surgeries or procedures excluded by the protocol.
  • Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
  • Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.
  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Other protocol-specified exclusion criteria may apply.

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): NCT02003391


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Project Lead GCRA, Pharma Alcon Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02003391    
Other Study ID Numbers: M-13-038
First Posted: December 6, 2013    Key Record Dates
Results First Posted: August 8, 2016
Last Update Posted: August 8, 2016
Last Verified: June 2016
Keywords provided by Alcon Research:
Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Travoprost
Ophthalmic Solutions
Adrenergic beta-Antagonists
Pharmaceutical Solutions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents