Latanoprost Versus Fotil

This study has been completed.
Sponsor:
Information provided by:
Pharmaceutical Research Network
ClinicalTrials.gov Identifier:
NCT00304785
First received: March 17, 2006
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: latanoprost 0.005%
Drug: Fotil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pharmaceutical Research Network:

Estimated Enrollment: 36
Study Start Date: May 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00304785

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

No publications provided

ClinicalTrials.gov Identifier: NCT00304785     History of Changes
Other Study ID Numbers: PRN 03-026
Study First Received: March 17, 2006
Last Updated: October 23, 2007
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Glaucoma
Vascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014