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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
History of Changes
  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:

Drug Information available for: Latanoprost
U.S. FDA Resources

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
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
Katdra Klinika Okulityki Akademii Medycznej w Warszawie
Warsaw, Poland, 02-005
Instytut Jaskry
Warsaw, Poland, 00415
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
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013