Clinical trial NCT01379144: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: 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.
timeFrame: Baseline and Day 28
measure: The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
timeFrame: Baseline and Day 28
measure: Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Eye Associates Pty Limited
state: New South Wales
city: Sydney
country: Australia
facility: Save Sight Institute
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, North Terrace
state: South Australia
city: Brno
country: Czechia
facility: University Hospital Brno-Bohunice
city: Prague 5
country: Czechia
facility: Private Ophthalmology, V Hurkach 1296
city: Prague 9
country: Czechia
facility: Institute of Aviation Medicine, Generalal Piky 1
city: Praha 2
country: Czechia
facility: Specializovana Glaukomova Poradna, Blanicka 25
city: Praha 2
country: Czechia
facility: VseobecnBfakultnf nemocnice
city: Marseille
country: France
facility: Hopital De La Timone
city: Marseille
country: France
facility: Hopital Des Armees Laveran
city: Paris
country: France
facility: Fondation Adolphe De Rothchild
city: Strasbourg
country: France
facility: Hopital Civil
city: Thessaloniki
country: Greece
facility: Akadimos Ophthalmology Center of Northern Greece
city: Lahore
country: Pakistan
facility: Layton Rahmatullah Benevolent Trust (LRBT), Eye Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: Services Hospital Lahore
state: Punjab
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital Karachi
state: Sindh
city: Karachi
country: Pakistan
facility: Civil Hospital Karachi
state: Sindh
city: Coimbra
country: Portugal
facility: A.I.B.I.L.I.
city: Lisboa
country: Portugal
facility: Hospital De S. Jose
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Ophthalmology
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.