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

December 1, 2011
May 13, 2013
July 2004
February 2012   (final data collection date for primary outcome measure)
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.
Melanin Granule Count [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
A trabecular meshwork tissue sample will be collected by the investigator. The number of pigment granules will be counted for three separate microscopic fields of view. Mean melanin granule count will be calculated.
Complete list of historical versions of study NCT01485822 on ClinicalTrials.gov Archive Site
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A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution
A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Open-angle Glaucoma
  • 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
  • TRAVATAN
    As prescribed by physician for the treatment of open-angle glaucoma and dosed for at least two years
    Interventions:
    • Procedure: Trabecular Meshwork Tissue Collection
    • Drug: Travoprost 0.004% ophthalmic solution
  • Treatment Naive
    No prior exposure (or less than 1 month) to any topical, ocular prostaglandin analogue
    Intervention: Procedure: Trabecular Meshwork Tissue Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01485822
C-01-78
No
Alcon Research
Alcon Research
Not Provided
Study Director: Theresa Landry, PhD Alcon Research
Alcon Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP