An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

NCT01664039 | Completed Phase 4 Results

• 2 other identifiers: RDG-11-2442012-002078-30
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6

  IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

  Baseline (Day 0), Month 6

Secondary Outcomes (7)

• Mean Change From Baseline in IOP at Week 6 and Month 3

  Baseline (Day 0), Week 6, Month 3

• Percentage of Subjects Who Reached Target IOP at Each Visit

  Week 6, Month 3, Month 6

• Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit

  Baseline (Day 0), Week 6, Month 3, Month 6

• Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6

  Baseline (Day 0), Month 3, Month 6

• Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6

  Baseline (Day 0), Month 3, Month 6

Study Arms (2)

TRAVATAN

EXPERIMENTAL

Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months

Drug: Travoprost 0.004% ophthalmic solution

LUMIGAN

ACTIVE COMPARATOR

Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months

Drug: Bimatoprost 0.01% ophthalmic solution

Interventions

Travoprost 0.004% ophthalmic solution DRUG

Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative

Also known as: TRAVATAN®

TRAVATAN

Bimatoprost 0.01% ophthalmic solution DRUG

Ophthalmic solution containing benzalkonium chloride (BAK)

Also known as: LUMIGAN®

LUMIGAN

Eligibility Criteria

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

You may qualify if:

• Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
• Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
• IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
• Able to follow instructions and be willing and able to attend all study visits.
• Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
• Must read, sign, and date an Ethics Committee-approved informed consent form.

You may not qualify if:

• Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
• Any abnormality preventing reliable applanation tonometry in either eye.
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
• Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
• History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
• Contact lens wear.
• Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
• Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
• Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
• Unwilling to risk the possibility of darkened iris or eyelash changes.
• Participation in any other investigational study within 30 days prior to the Screening Visit.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Travoprost; Ophthalmic Solutions; Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Amides; Organic Chemicals

Results Point of Contact

• Title: Global Brand Lead, Medical Affairs, Glaucoma
• Organization: Alcon Research, Ltd

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 3, 2015
• Results First Posted: July 14, 2015

Record last verified: 2015-07