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Latanoprost Versus Fotil

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
latanoprost 0.005%
Fotil
placebo
Sponsored by
Pharmaceutical Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gabinety Okulistyczne
  • Kierownik Kliniki Okulistycznej Akademii Medycznej
  • Instytut Jaskry
  • Katdra Klinika Okulityki Akademii Medycznej w Warszawie
  • Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 17, 2006
Last Updated
October 23, 2007
Sponsor
Pharmaceutical Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00304785
Brief Title
Latanoprost Versus Fotil
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmaceutical Research Network

4. Oversight

5. Study Description

Brief Summary
To compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus PTFC given twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005%
Intervention Type
Drug
Intervention Name(s)
Fotil
Intervention Type
Drug
Intervention Name(s)
placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Stewart, MD
Organizational Affiliation
Pharmaceutical Research Network, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Józef Kałużny, Professor
Organizational Affiliation
Gabinety Okulistyczne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krystyna Pecold, Professor
Organizational Affiliation
Kierownik Kliniki Okulistycznej Akademii Medycznej
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roman Sobecki, Dr. n.med.
Organizational Affiliation
Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krystyna Czechowisz-Janicka, Professor
Organizational Affiliation
Instytut Jaskry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dariusz Kecik, Professor
Organizational Affiliation
Katdra Klinika Okulityki Akademii Medycznej w Warszawie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gabinety Okulistyczne
City
Bydgoszcz
ZIP/Postal Code
PL-85-670
Country
Poland
Facility Name
Kierownik Kliniki Okulistycznej Akademii Medycznej
City
Poznan'
ZIP/Postal Code
PL-61-848
Country
Poland
Facility Name
Instytut Jaskry
City
Warsaw
ZIP/Postal Code
00415
Country
Poland
Facility Name
Katdra Klinika Okulityki Akademii Medycznej w Warszawie
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny
City
Warszawa
ZIP/Postal Code
PL-04-749
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Latanoprost Versus Fotil

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