A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular Hypertension

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A 4 Week, Dose-Ranging, Multi-Center, Randomized, Double-Masked, Parallel Study Comparing The Efficacy, Safety, And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma Aand Ocular Hypertension

The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Save Sight Institute
      • Sydney, New South Wales, Australia, 2000
        • Eye Associates Pty Limited
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital, North Terrace
  • Czechia
      • Brno, Czechia, CZ - 62500
        • University Hospital Brno-Bohunice
      • Prague 5, Czechia, 150 00
        • Private Ophthalmology, V Hurkach 1296
      • Prague 9, Czechia, 160 60
        • Institute of Aviation Medicine, Generalal Piky 1
      • Praha 2, Czechia, 120 00
        • Specializovana Glaukomova Poradna, Blanicka 25
      • Praha 2, Czechia, 128 21
        • VseobecnBfakultnf nemocnice
  • France
      • Marseille, France
        • Hopital de la Timone
      • Marseille, France
        • Hopital Des Armees Laveran
      • Paris, France, 75016
        • Fondation Adolphe De Rothchild
      • Strasbourg, France
        • Hôpital CIVIL
  • Greece
      • Thessaloniki, Greece
        • Akadimos Ophthalmology Center of Northern Greece
  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Services Hospital Lahore
      • Lahore, Punjab, Pakistan
        • Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
    • Sindh
      • Karachi, Sindh, Pakistan
        • Civil Hospital Karachi
      • Karachi, Sindh, Pakistan
        • Aga Khan University Hospital Karachi
  • Portugal
      • Coimbra, Portugal, 3000
        • A.I.B.I.L.I.
      • Lisboa, Portugal
        • Hospital De S. Jose
      • Matosinhos, Portugal
        • Hospital Pedro Hispano
  • Thailand
      • Bangkok, Thailand
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Ophthalmology
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Glasgow, United Kingdom, G4 0SF
        • Glasgow Royal Infirmary
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 18 years of age or older.
  • Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment.
  • IOP between ≥ 24 mmHg and ≤ 36 mmHg in at least one eye at the 8 AM time point at baseline/randomization.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure.
  • A history of discontinued prostaglandin IOP lowering treatment, unless the reason for discontinuation was participation in a clinical study.
  • Ocular surgery or argon laser trabeculoplasty in one or both eyes within 3 months prior to the screening visit.
  • Use or anticipated requirement during the study of any topical medication that was known to affect IOP.
  • Anticipated need to modify systemic medication known to affect IOP (eg, beta-adrenergic antagonists, alpha-adrenergic agonists, calcium channel blockers, angiotension converting enzyme inhibitors, and angiotension II receptor antagonists) during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: latanoprost 75 ug
Drug: latanoprost 75 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
Experimental: latanoprost 100 ug
Drug: latanoprost 100 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
Experimental: latanoprost 125 ug
Drug: latanoprost 125 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
Active Comparator: latanoprost 50 ug
Drug: latanoprost 50 ug

Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).

Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
Time Frame: Baseline and Day 28
Baseline and Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit.
Time Frame: Baseline and Day 28
Baseline and Day 28
The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
Time Frame: Baseline and Day 28
Baseline and Day 28
Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.
Time Frame: Baseline and Day 28
Baseline and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XALA-0091-166
  • A6111066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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