NCT00304785

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2005

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 24, 2007

Status Verified

October 1, 2007

First QC Date

March 17, 2006

Last Update Submit

October 23, 2007

Conditions

Open-Angle GlaucomaOcular Hypertension

Interventions

latanoprost 0.005%DRUG
FotilDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • presence of exfoliation syndrome or exfoliation glaucoma
  • contraindications to study medications
  • any anticipated change in systemic hypotensive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gabinety Okulistyczne

Bydgoszcz, PL-85-670, Poland

Location

Kierownik Kliniki Okulistycznej Akademii Medycznej

Poznan, PL-61-848, Poland

Location

Instytut Jaskry

Warsaw, 00415, Poland

Location

Katdra Klinika Okulityki Akademii Medycznej w Warszawie

Warsaw, 02-005, Poland

Location

Ordynator Oddziału Okulistycznego Międzyleski Szpital Specjalistyczny

Warsaw, PL-04-749, Poland

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 20, 2006

Study Start

May 1, 2005

Study Completion

October 1, 2007

Last Updated

October 24, 2007

Record last verified: 2007-10

Locations

PL(5)