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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379144
• Other study ID #: XALA-0091-166
• Secondary ID: A6111066
• Status: Completed
• Phase: Phase 2
• Start date: January 2003
• Est. completion date: April 2003

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: April 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital, North Terrace	Adelaide	South Australia
Australia	Eye Associates Pty Limited	Sydney	New South Wales
Australia	Save Sight Institute	Sydney	New South Wales
Czechia	University Hospital Brno-Bohunice	Brno
Czechia	Private Ophthalmology, V Hurkach 1296	Prague 5
Czechia	Institute of Aviation Medicine, Generalal Piky 1	Prague 9
Czechia	Specializovana Glaukomova Poradna, Blanicka 25	Praha 2
Czechia	VseobecnBfakultnf nemocnice	Praha 2
France	Hopital De La Timone	Marseille
France	Hopital Des Armees Laveran	Marseille
France	Fondation Adolphe De Rothchild	Paris
France	Hopital Civil	Strasbourg
Greece	Akadimos Ophthalmology Center of Northern Greece	Thessaloniki
Pakistan	Aga Khan University Hospital Karachi	Karachi	Sindh
Pakistan	Civil Hospital Karachi	Karachi	Sindh
Pakistan	Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital	Lahore	Punjab
Pakistan	Services Hospital Lahore	Lahore	Punjab
Portugal	A.I.B.I.L.I.	Coimbra
Portugal	Hospital De S. Jose	Lisboa
Portugal	Hospital Pedro Hispano	Matosinhos
Thailand	Chulalongkorn Hospital	Bangkok
Thailand	Siriraj Hospital, Ophthalmology	Bangkok
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Sunderland Eye Infirmary	Sunderland

Sponsors (1)

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

Countries where clinical trial is conducted

Australia,  Czechia,  France,  Greece,  Pakistan,  Portugal,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).		Baseline and Day 28
Secondary	Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.		Baseline and Day 28

External Links

•   To obtain contact information for a study center near you, click here.