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

Tracking Information

First Received Date ^ICMJE

March 17, 2006

Last Updated Date

October 23, 2007

Start Date ^ICMJE

May 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00304785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Latanoprost Versus Fotil

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Open-Angle Glaucoma
Ocular Hypertension

Intervention ^ICMJE

Drug: latanoprost 0.005%
Drug: Fotil
Drug: placebo

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00304785

Other Study ID Numbers ^ICMJE

PRN 03-026

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pharmaceutical Research Network

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Pharmaceutical Research Network

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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