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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

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ClinicalTrials.gov Identifier: NCT01485822
Recruitment Status : Terminated (Study objectives met)
First Posted : December 6, 2011
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment
Open-angle Glaucoma Procedure: Trabecular Meshwork Tissue Collection Drug: Travoprost 0.004% ophthalmic solution

Study Type : Observational
Actual Enrollment : 88 participants
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
Study Start Date : July 2004
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Melanin Granule Count [ Time Frame: Day 1 ]
    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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01485822


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01485822     History of Changes
Other Study ID Numbers: C-01-78
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Alcon Research:
Glaucoma
Travatan
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Travoprost
Antihypertensive Agents