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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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
latanoprost 75 ug
latanoprost 100 ug
latanoprost 125 ug
latanoprost 50 ug
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eye Associates Pty Limited
  • Save Sight Institute
  • Royal Adelaide Hospital, North Terrace
  • University Hospital Brno-Bohunice
  • Private Ophthalmology, V Hurkach 1296
  • Institute of Aviation Medicine, Generalal Piky 1
  • Specializovana Glaukomova Poradna, Blanicka 25
  • VseobecnBfakultnf nemocnice
  • Hopital De La Timone
  • Hopital Des Armees Laveran
  • Fondation Adolphe De Rothchild
  • Hopital Civil
  • Akadimos Ophthalmology Center of Northern Greece
  • Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
  • Services Hospital Lahore
  • Aga Khan University Hospital Karachi
  • Civil Hospital Karachi
  • A.I.B.I.L.I.
  • Hospital De S. Jose
  • Hospital Pedro Hispano
  • Siriraj Hospital, Ophthalmology
  • Chulalongkorn Hospital
  • Birmingham Heartlands Hospital
  • Glasgow Royal Infirmary
  • Sunderland Eye Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

latanoprost 75 ug

latanoprost 100 ug

latanoprost 125 ug

latanoprost 50 ug

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.

Full Information

First Posted
June 20, 2011
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01379144
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
latanoprost 75 ug
Arm Type
Experimental
Arm Title
latanoprost 100 ug
Arm Type
Experimental
Arm Title
latanoprost 125 ug
Arm Type
Experimental
Arm Title
latanoprost 50 ug
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
latanoprost 75 ug
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
latanoprost 100 ug
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
latanoprost 125 ug
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
latanoprost 50 ug
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
Time Frame
Baseline and Day 28
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Eye Associates Pty Limited
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Save Sight Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Royal Adelaide Hospital, North Terrace
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
University Hospital Brno-Bohunice
City
Brno
ZIP/Postal Code
CZ - 62500
Country
Czechia
Facility Name
Private Ophthalmology, V Hurkach 1296
City
Prague 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Institute of Aviation Medicine, Generalal Piky 1
City
Prague 9
ZIP/Postal Code
160 60
Country
Czechia
Facility Name
Specializovana Glaukomova Poradna, Blanicka 25
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
VseobecnBfakultnf nemocnice
City
Praha 2
ZIP/Postal Code
128 21
Country
Czechia
Facility Name
Hopital De La Timone
City
Marseille
Country
France
Facility Name
Hopital Des Armees Laveran
City
Marseille
Country
France
Facility Name
Fondation Adolphe De Rothchild
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
Hopital Civil
City
Strasbourg
Country
France
Facility Name
Akadimos Ophthalmology Center of Northern Greece
City
Thessaloniki
Country
Greece
Facility Name
Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Aga Khan University Hospital Karachi
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Civil Hospital Karachi
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
A.I.B.I.L.I.
City
Coimbra
ZIP/Postal Code
3000
Country
Portugal
Facility Name
Hospital De S. Jose
City
Lisboa
Country
Portugal
Facility Name
Hospital Pedro Hispano
City
Matosinhos
Country
Portugal
Facility Name
Siriraj Hospital, Ophthalmology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chulalongkorn Hospital
City
Bangkok
Country
Thailand
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Sunderland Eye Infirmary
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22607109
Citation
Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 mug/mL to latanoprost 50 mug/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XALA-0091-166
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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