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

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: latanoprost 100 ug; Drug: latanoprost 75 ug; Drug: latanoprost 125 ug; Drug: latanoprost 50 ug

• Registration Number: NCT01379144
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-03
• Study Completion: 2003-04
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Status Verified: 2018-09
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
latanoprost 100 ug	latanoprost 100 ug	-
latanoprost 75 ug	latanoprost 75 ug	-
latanoprost 125 ug	latanoprost 125 ug	-
latanoprost 50 ug	latanoprost 50 ug	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

Royal Adelaide Hospital, North Terrace; 🇦🇺 Adelaide, South Australia, Australia

Aga Khan University Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan

Civil Hospital Karachi; 🇵🇰 Karachi, Sindh, Pakistan

Save Sight Institute; 🇦🇺 Sydney, New South Wales, Australia

Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Hospital De S. Jose; 🇵🇹 Lisboa, Portugal

Akadimos Ophthalmology Center of Northern Greece; 🇬🇷 Thessaloniki, Greece

Hopital De La Timone; 🇫🇷 Marseille, France

Specializovana Glaukomova Poradna, Blanicka 25; 🇨🇿 Praha 2, Czechia

Hopital Civil; 🇫🇷 Strasbourg, France

Eye Associates Pty Limited; 🇦🇺 Sydney, New South Wales, Australia

Glasgow Royal Infirmary; 🇬🇧 Glasgow, United Kingdom

Hopital Des Armees Laveran; 🇫🇷 Marseille, France

Fondation Adolphe De Rothchild; 🇫🇷 Paris, France

Siriraj Hospital, Ophthalmology; 🇹🇭 Bangkok, Thailand

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Private Ophthalmology, V Hurkach 1296; 🇨🇿 Prague 5, Czechia

A.I.B.I.L.I.; 🇵🇹 Coimbra, Portugal

Hospital Pedro Hispano; 🇵🇹 Matosinhos, Portugal

University Hospital Brno-Bohunice; 🇨🇿 Brno, Czechia

VseobecnBfakultnf nemocnice; 🇨🇿 Praha 2, Czechia

Institute of Aviation Medicine, Generalal Piky 1; 🇨🇿 Prague 9, Czechia

Services Hospital Lahore; 🇵🇰 Lahore, Punjab, Pakistan

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Sunderland Eye Infirmary; 🇬🇧 Sunderland, United Kingdom