A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

This study has been terminated.
(Study objectives met)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01485822
First received: December 1, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).


Condition Intervention Phase
Open-angle Glaucoma
Procedure: Trabecular Meshwork Tissue Collection
Drug: Travoprost 0.004% ophthalmic solution
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Melanin Granule Count [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    A trabecular meshwork tissue sample was collected by the investigator. The number of pigment granules was counted for three separate microscopic fields of view. Mean melanin granule count was calculated.


Enrollment: 88
Study Start Date: July 2004
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TRAVATAN
As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
Procedure: Trabecular Meshwork Tissue Collection
A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.
Drug: Travoprost 0.004% ophthalmic solution
Other Names:
  • TRAVATAN Z
  • TRAVATAN
Treatment Naive
No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue
Procedure: Trabecular Meshwork Tissue Collection
A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients were identified and enrolled from 9 study centers in the US and 1 in Spain.

Criteria

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
  • Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
  • Requires a trabeculectomy;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pseudoexfoliation or pigment dispersion;
  • History of chronic or recurrent severe inflammatory eye disease;
  • History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
  • Greater than one month but less than two years of exposure to TRAVATAN;
  • Pregnant, breast-feeding, not using highly effective birth control;
  • 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485822

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01485822     History of Changes
Other Study ID Numbers: C-01-78
Study First Received: December 1, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Glaucoma
Travatan
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Travoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014