An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01664039
First received: August 10, 2012
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004% ophthalmic solution
Drug: Bimatoprost 0.01% ophthalmic solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 [ Time Frame: Baseline (Day 0), Month 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline in IOP at Week 6 and Month 3 [ Time Frame: Baseline (Day 0), Week 6, Month 3 ] [ Designated as safety issue: No ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in 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.

  • Percentage of Subjects Who Reached Target IOP at Each Visit [ Time Frame: Week 6, Month 3, Month 6 ] [ Designated as safety issue: No ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

  • Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit [ Time Frame: Baseline (Day 0), Week 6, Month 3, Month 6 ] [ Designated as safety issue: No ]
    Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

  • Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 [ Time Frame: Baseline (Day 0), Month 3, Month 6 ] [ Designated as safety issue: No ]
    Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

  • Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 [ Time Frame: Baseline (Day 0), Month 3, Month 6 ] [ Designated as safety issue: No ]
    Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.

  • Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 [ Time Frame: Baseline (Day 0), Month 3, Month 6 ] [ Designated as safety issue: No ]
    The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.

  • Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 [ Time Frame: Baseline (Day 0), Month 3, Month 6 ] [ Designated as safety issue: No ]
    TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.


Enrollment: 104
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRAVATAN
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
Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
Other Name: TRAVATAN®
Active Comparator: LUMIGAN
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
Ophthalmic solution containing benzalkonium chloride (BAK)
Other Name: LUMIGAN®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01664039     History of Changes
Other Study ID Numbers: RDG-11-244, 2012-002078-30
Study First Received: August 10, 2012
Results First Received: June 19, 2015
Last Updated: June 19, 2015
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee

Keywords provided by Alcon Research:
Glaucoma
Ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015