Latanoprost Versus Fotil

October 23, 2007 updated by: Pharmaceutical Research Network
To compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus PTFC given twice daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, PL-85-670
        • Gabinety Okulistyczne
      • Poznan', Poland, PL-61-848
        • Kierownik Kliniki Okulistycznej Akademii Medycznej
      • Warsaw, Poland, 00415
        • Instytut Jaskry
      • Warsaw, Poland, 02-005
        • Katdra Klinika Okulityki Akademii Medycznej w Warszawie
      • Warszawa, Poland, PL-04-749
        • Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults with primary open-angle or pigment dispersion glaucoma, or ocular hypertension
  • untreated intraocular pressure should be between 24-36 mm Hg inclusive
  • visual acuity should be 5/50 or better in both eyes

Exclusion Criteria:

  • presence of exfoliation syndrome or exfoliation glaucoma
  • contraindications to study medications
  • any anticipated change in systemic hypotensive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaceutical Research Network

Investigators

  • Study Director: William C. Stewart, MD, Pharmaceutical Research Network, LLC
  • Principal Investigator: Józef Kałużny, Professor, Gabinety Okulistyczne
  • Principal Investigator: Krystyna Pecold, Professor, Kierownik Kliniki Okulistycznej Akademii Medycznej
  • Principal Investigator: Roman Sobecki, Dr. n.med., Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny
  • Principal Investigator: Krystyna Czechowisz-Janicka, Professor, Instytut Jaskry
  • Principal Investigator: Dariusz Kecik, Professor, Katdra Klinika Okulityki Akademii Medycznej w Warszawie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 17, 2006

First Posted (Estimate)

March 20, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2007

Last Update Submitted That Met QC Criteria

October 23, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRN 03-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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