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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00304785
Other study ID # PRN 03-026
Secondary ID
Status Completed
Phase Phase 4
First received March 17, 2006
Last updated October 23, 2007
Start date May 2005
Est. completion date October 2007

Study information

Verified date October 2007
Source Pharmaceutical Research Network
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
latanoprost 0.005%

Fotil

placebo


Locations

Country Name City State
Poland Gabinety Okulistyczne Bydgoszcz
Poland Kierownik Kliniki Okulistycznej Akademii Medycznej Poznan'
Poland Instytut Jaskry Warsaw
Poland Katdra Klinika Okulityki Akademii Medycznej w Warszawie Warsaw
Poland Ordynator Oddzialu Okulistycznego Miedzyleski Szpital Specjalistyczny Warszawa

Sponsors (1)

Lead Sponsor Collaborator
Pharmaceutical Research Network

Country where clinical trial is conducted

Poland, 

See also
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