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
NCT ID: NCT01379144
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
282 participants
INTERVENTIONAL
2003-01-31
2003-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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latanoprost 75 ug
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.
latanoprost 100 ug
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.
latanoprost 125 ug
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.
latanoprost 50 ug
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Eye Associates Pty Limited
Sydney, New South Wales, Australia
Save Sight Institute
Sydney, New South Wales, Australia
Royal Adelaide Hospital, North Terrace
Adelaide, South Australia, Australia
University Hospital Brno-Bohunice
Brno, , Czechia
Specializovana Glaukomova Poradna, Blanicka 25
Prague, , Czechia
VseobecnBfakultnf nemocnice
Prague, , Czechia
Private Ophthalmology, V Hurkach 1296
Prague, , Czechia
Institute of Aviation Medicine, Generalal Piky 1
Prague, , Czechia
Hopital De La Timone
Marseille, , France
Hopital Des Armees Laveran
Marseille, , France
Fondation Adolphe De Rothchild
Paris, , 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, , Portugal
Hospital De S. Jose
Lisbon, , Portugal
Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Siriraj Hospital, Ophthalmology
Bangkok, , Thailand
Chulalongkorn Hospital
Bangkok, , Thailand
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6111066
Identifier Type: -
Identifier Source: secondary_id
XALA-0091-166
Identifier Type: -
Identifier Source: org_study_id
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