A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.139 enrolled

Overview

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

139

Conditions

Glaucoma

Interventions

TimololDRUG

Timolol 0.5% dosed twice-daily

latanoprostDRUG

Latanoprost 0.005% ophthalmic solution dosed once-daily

Eligibility

Sex: ALLMin age: 36 WeeksMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female of 18 years of age or under * Diagnosis of glaucoma * IOP of 22 mmHg or above in at least 1 eye Exclusion Criteria: * Require surgery for acute angle closure * Have had prior cyclodestructive procedures * Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

Locations (48)

Outcomes

Primary Outcomes

Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)

Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Time frame: Baseline, Week 12

Secondary Outcomes

Reduction From Baseline in Mean IOP at Week 1

Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Time frame: Baseline, Week 1

Reduction From Baseline in Mean IOP at Week 4

Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Time frame: Baseline, Week 4

Reduction From Baseline in Mean IOP at Week 12 (Observed)

Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Pembroke Pines, Florida, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Pfizer Investigational Site

Indianapolis, Indiana, United States

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Pfizer Investigational Site

Henderson, Nevada, United States

Pfizer Investigational Site

Henderson, Nevada, United States

Pfizer Investigational Site

Las Vegas, Nevada, United States

Pfizer Investigational Site

Leuven, Belgium

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

...and 38 more locations

Time frame: Baseline, Week 12

Mean IOP at Baseline

IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Time frame: Baseline

Mean IOP at Week 1

Time frame: Week 1

Mean IOP at Week 4

Time frame: Week 4

Mean IOP at Week 12

Time frame: Week 12

Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12

Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

Time frame: Baseline, Week 4, and Week 12

Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience

An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.

Time frame: Baseline through Week 12