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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01379144




Registration number
NCT01379144
Ethics application status
Date submitted
20/06/2011
Date registered
23/06/2011
Date last updated
2/02/2021

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
A6111066
Secondary ID [2] 0 0
XALA-0091-166
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Open Angle Glaucoma 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - latanoprost 75 ug
Treatment: Drugs - latanoprost 100 ug
Treatment: Drugs - latanoprost 125 ug
Treatment: Drugs - latanoprost 50 ug

Experimental: latanoprost 75 ug -

Experimental: latanoprost 100 ug -

Experimental: latanoprost 125 ug -

Active Comparator: latanoprost 50 ug -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
Timepoint [1] 0 0
Baseline and Day 28
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and Day 28
Secondary outcome [2] 0 0
The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
Timepoint [2] 0 0
Baseline and Day 28
Secondary outcome [3] 0 0
Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.
Timepoint [3] 0 0
Baseline and Day 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2003
Sample size
Target
Accrual to date
Final
282
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Eye Associates Pty Limited - Sydney
Recruitment hospital [2] 0 0
Save Sight Institute - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital, North Terrace - Adelaide
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague 5
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague 9
Country [4] 0 0
Czechia
State/province [4] 0 0
Praha 2
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Strasbourg
Country [8] 0 0
Greece
State/province [8] 0 0
Thessaloniki
Country [9] 0 0
Pakistan
State/province [9] 0 0
Punjab
Country [10] 0 0
Pakistan
State/province [10] 0 0
Sindh
Country [11] 0 0
Portugal
State/province [11] 0 0
Coimbra
Country [12] 0 0
Portugal
State/province [12] 0 0
Lisboa
Country [13] 0 0
Portugal
State/province [13] 0 0
Matosinhos
Country [14] 0 0
Thailand
State/province [14] 0 0
Bangkok
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Birmingham
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Glasgow
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01379144
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01379144