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
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
2 other identifiers
interventional
282
8 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2003
Shorter than P25 for phase_2
25 active sites
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
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedFebruary 2, 2021
September 1, 2018
2 months
June 20, 2011
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
Baseline and Day 28
Secondary Outcomes (3)
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.
Baseline and Day 28
The percentage change in IOP from baseline at 8 AM to Week 4 (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.
Baseline and Day 28
Study Arms (4)
latanoprost 75 ug
EXPERIMENTALlatanoprost 100 ug
EXPERIMENTALlatanoprost 125 ug
EXPERIMENTALlatanoprost 50 ug
ACTIVE COMPARATORInterventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Eye Associates Pty Limited
Sydney, New South Wales, 2000, Australia
Save Sight Institute
Sydney, New South Wales, 2000, Australia
Royal Adelaide Hospital, North Terrace
Adelaide, South Australia, 5000, Australia
University Hospital Brno-Bohunice
Brno, CZ - 62500, Czechia
Specializovana Glaukomova Poradna, Blanicka 25
Prague, 120 00, Czechia
VseobecnBfakultnf nemocnice
Prague, 128 21, Czechia
Private Ophthalmology, V Hurkach 1296
Prague, 150 00, Czechia
Institute of Aviation Medicine, Generalal Piky 1
Prague, 160 60, Czechia
Hopital De La Timone
Marseille, France
Hopital Des Armees Laveran
Marseille, France
Fondation Adolphe De Rothchild
Paris, 75016, France
Hopital Civil
Strasbourg, France
Akadimos Ophthalmology Center of Northern Greece
Thessaloniki, Greece
Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
Lahore, Punjab Province, Pakistan
Services Hospital Lahore
Lahore, Punjab Province, Pakistan
Aga Khan University Hospital Karachi
Karachi, Sindh, Pakistan
Civil Hospital Karachi
Karachi, Sindh, Pakistan
A.I.B.I.L.I.
Coimbra, 3000, Portugal
Hospital De S. Jose
Lisbon, Portugal
Hospital Pedro Hispano
Matosinhos Municipality, Portugal
Siriraj Hospital, Ophthalmology
Bangkok, 10700, Thailand
Chulalongkorn Hospital
Bangkok, Thailand
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
Related Publications (1)
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.
PMID: 22607109DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 23, 2011
Study Start
January 1, 2003
Primary Completion
March 1, 2003
Study Completion
April 1, 2003
Last Updated
February 2, 2021
Record last verified: 2018-09