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Latanoprost Versus Fotil

NCT ID: NCT00304785

Last Updated: 2007-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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Conditions

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Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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latanoprost 0.005%

Intervention Type DRUG

Fotil

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research Network

OTHER

Sponsor Role lead

Principal Investigators

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William C. Stewart, MD

Role: STUDY_DIRECTOR

Pharmaceutical Research Network, LLC

Józef Kałużny, Professor

Role: PRINCIPAL_INVESTIGATOR

Gabinety Okulistyczne

Krystyna Pecold, Professor

Role: PRINCIPAL_INVESTIGATOR

Kierownik Kliniki Okulistycznej Akademii Medycznej

Roman Sobecki, Dr. n.med.

Role: PRINCIPAL_INVESTIGATOR

Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny

Krystyna Czechowisz-Janicka, Professor

Role: PRINCIPAL_INVESTIGATOR

Instytut Jaskry

Dariusz Kecik, Professor

Role: PRINCIPAL_INVESTIGATOR

Katdra Klinika Okulityki Akademii Medycznej w Warszawie

Locations

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Gabinety Okulistyczne

Bydgoszcz, , Poland

Site Status

Kierownik Kliniki Okulistycznej Akademii Medycznej

Poznan, , Poland

Site Status

Instytut Jaskry

Warsaw, , Poland

Site Status

Katdra Klinika Okulityki Akademii Medycznej w Warszawie

Warsaw, , Poland

Site Status

Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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PRN 03-026

Identifier Type: -

Identifier Source: org_study_id