A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Timolol
|
Drug: Timolol
Timolol 0.5% dosed twice-daily
|
Experimental: latanoprost
|
Drug: latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily
|
Outcome Measures
Primary Outcome Measures
- Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) [Baseline, Week 12]
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.
Secondary Outcome Measures
- Reduction From Baseline in Mean IOP at Week 1 [Baseline, 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.
- Reduction From Baseline in Mean IOP at Week 4 [Baseline, 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.
- Reduction From Baseline in Mean IOP at Week 12 (Observed) [Baseline, Week 12]
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.
- Mean IOP at Baseline [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.
- Mean IOP at Week 1 [Week 1]
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.
- Mean IOP at Week 4 [Week 4]
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.
- Mean IOP at Week 12 [Week 12]
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.
- Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12 [Baseline, Week 4, and Week 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.
- Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience [Baseline through Week 12]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Pfizer Investigational Site | Pembroke Pines | Florida | United States | 33028 |
2 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30322 |
3 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46202 |
4 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55455 |
5 | Pfizer Investigational Site | Henderson | Nevada | United States | 89052 |
6 | Pfizer Investigational Site | Henderson | Nevada | United States | 89074 |
7 | Pfizer Investigational Site | Las Vegas | Nevada | United States | 89148 |
8 | Pfizer Investigational Site | Leuven | Belgium | 3000 | |
9 | Pfizer Investigational Site | Medellín | Antioquia | Colombia | 0000 |
10 | Pfizer Investigational Site | Bogota | Cundinamarca | Colombia | 0000 |
11 | Pfizer Investigational Site | Praha 5 | Czechia | 150 06 | |
12 | Pfizer Investigational Site | Amiens | Cedex 1 | France | 80054 |
13 | Pfizer Investigational Site | Lille Cedex | France | 59037 | |
14 | Pfizer Investigational Site | Lyon | France | 69437 | |
15 | Pfizer Investigational Site | Regenstauf | Germany | 93128 | |
16 | Pfizer Investigational Site | Schorndorf | Germany | 73614 | |
17 | Pfizer Investigational Site | Hyderabad | Andhra Pradesh | India | 500034 |
18 | Pfizer Investigational Site | Ahmedabad | Gujarat | India | 380004 |
19 | Pfizer Investigational Site | Coimbatore | Tamilnadu | India | 641 014 |
20 | Pfizer Investigational Site | Catania | Italy | 95123 | |
21 | Pfizer Investigational Site | Milano | Italy | 20162 | |
22 | Pfizer Investigational Site | Makati City | Philippines | 1200 | |
23 | Pfizer Investigational Site | Mandaluyong City | Philippines | 1500 | |
24 | Pfizer Investigational Site | Bialystok | Poland | 15-274 | |
25 | Pfizer Investigational Site | Gdansk | Poland | 80-211 | |
26 | Pfizer Investigational Site | Wroclaw | Poland | 50-368 | |
27 | Pfizer Investigational Site | Coimbra | Portugal | 3000-548 | |
28 | Pfizer Investigational Site | Lisboa | Portugal | 1169-019 | |
29 | Pfizer Investigational Site | Lisboa | Portugal | 1169-097 | |
30 | Pfizer Investigational Site | Lisboa | Portugal | 1649-035 | |
31 | Pfizer Investigational Site | Porto | Portugal | 4099-001 | |
32 | Pfizer Investigational Site | Cluj-Napoca | Cluj | Romania | 400006 |
33 | Pfizer Investigational Site | Moscow | Russian Federation | 119331 | |
34 | Pfizer Investigational Site | St. Petersburg | Russian Federation | 194100 | |
35 | Pfizer Investigational Site | Belgrade | Serbia | 11000 | |
36 | Pfizer Investigational Site | Bratislava | Slovakia | 83340 | |
37 | Pfizer Investigational Site | Ljubljana | Slovenia | 1000 | |
38 | Pfizer Investigational Site | Myfair West | South Africa | 2109 | |
39 | Pfizer Investigational Site | Esplugues de Llobregat | Barcelona | Spain | 08950 |
40 | Pfizer Investigational Site | Madrid | Spain | 28040 | |
41 | Pfizer Investigational Site | Sevilla | Spain | 41013 | |
42 | Pfizer Investigational Site | Kharkiv | Ukraine | 61000 | |
43 | Pfizer Investigational Site | Kyiv | Ukraine | 01135 | |
44 | Pfizer Investigational Site | Kyiv | Ukraine | 04050 | |
45 | Pfizer Investigational Site | Kyiv | Ukraine | ||
46 | Pfizer Investigational Site | Odesa | Ukraine | 65061 | |
47 | Pfizer Investigational Site | Birmingham | United Kingdom | B18 7QH | |
48 | Pfizer Investigational Site | London | United Kingdom | EC1V 2PD |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A6111137
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Randomization was stratified by age, diagnosis (congenital glaucoma [PCG] or non-congenital glaucoma [non-PCG], and intraocular pressure [IOP]) of the study eye at baseline. |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Period Title: Overall Study | ||
STARTED | 70 | 69 |
Received Treatment | 69 | 68 |
COMPLETED | 61 | 64 |
NOT COMPLETED | 9 | 5 |
Baseline Characteristics
Arm/Group Title | Timolol | Latanoprost | Total |
---|---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. | Total of all reporting groups |
Overall Participants | 69 | 68 | 137 |
Age, Customized (Number) [Number] | |||
12 to 18 years |
23
33.3%
|
25
36.8%
|
48
35%
|
3 to less than (<) 12 years |
29
42%
|
26
38.2%
|
55
40.1%
|
0 to < 3 years |
17
24.6%
|
17
25%
|
34
24.8%
|
Sex: Female, Male (Count of Participants) | |||
Female |
37
53.6%
|
34
50%
|
71
51.8%
|
Male |
32
46.4%
|
34
50%
|
66
48.2%
|
Outcome Measures
Title | Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF. |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 54 | 53 |
Least Squares Mean (Standard Error) [mmHg] |
5.72
(0.81)
|
7.18
(0.81)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Timolol, Latanoprost |
---|---|---|
Comments | Null hypothesis: latanoprost inferior to timolol (0.5 percent [%] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP. | |
Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
Comments | If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1.46 | |
Confidence Interval |
(2-Sided) 95% -0.81 to 3.74 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Reduction From Baseline in Mean IOP at Week 1 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 54 | 53 |
Least Squares Mean (Standard Error) [mmHg] |
6.02
(0.83)
|
6.70
(0.84)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Timolol, Latanoprost |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.68 | |
Confidence Interval |
(2-Sided) 95% -1.66 to 3.02 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Reduction From Baseline in Mean IOP at Week 4 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable participants in PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 47 | 49 |
Least Squares Mean (Standard Error) [mmHg] |
5.37
(0.94)
|
6.99
(0.92)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Timolol, Latanoprost |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1.62 | |
Confidence Interval |
(2-Sided) 95% -1.00 to 4.25 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Reduction From Baseline in Mean IOP at Week 12 (Observed) |
---|---|
Description | 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. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable participants in PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 43 | 46 |
Least Squares Mean (Standard Error) [mmHg] |
6.96
(0.68)
|
7.75
(0.66)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Timolol, Latanoprost |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.4085 | |
Confidence Interval |
(2-Sided) 95% -1.10 to 2.67 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Mean IOP at Baseline |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 54 | 53 |
Mean (Standard Deviation) [mmHg] |
27.8
(6.18)
|
27.3
(5.46)
|
Title | Mean IOP at Week 1 |
---|---|
Description | 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 | Week 1 |
Outcome Measure Data
Analysis Population Description |
---|
PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 54 | 53 |
Mean (Standard Deviation) [mmHg] |
21.7
(7.99)
|
20.6
(6.38)
|
Title | Mean IOP at Week 4 |
---|---|
Description | 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 | Week 4 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable participants in PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 47 | 49 |
Mean (Standard Deviation) [mmHg] |
21.5
(7.49)
|
20.1
(6.82)
|
Title | Mean IOP at Week 12 |
---|---|
Description | 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 | Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable participants in PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 43 | 46 |
Mean (Standard Deviation) [mmHg] |
19.8
(3.50)
|
19.2
(5.87)
|
Title | Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Evaluable participants in PP |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 54 | 53 |
Number (95% Confidence Interval) [Percentage of participants] |
52
75.4%
|
60
88.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Timolol, Latanoprost |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.3315 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments | P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG). |
Title | Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication. |
Arm/Group Title | Timolol | Latanoprost |
---|---|---|
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. |
Measure Participants | 69 | 68 |
Number [Percentage of particpants] |
1.4
|
0
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||
Arm/Group Title | Timolol | Latanoprost | ||
Arm/Group Description | Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM . | Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM. | ||
All Cause Mortality |
||||
Timolol | Latanoprost | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Timolol | Latanoprost | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/69 (10.1%) | 2/68 (2.9%) | ||
Congenital, familial and genetic disorders | ||||
Developmental glaucoma, both eyes | 1/69 (1.4%) | 0/68 (0%) | ||
Eye disorders | ||||
Angle closure glaucoma, both eyes | 1/69 (1.4%) | 0/68 (0%) | ||
Glaucoma, both eyes | 1/69 (1.4%) | 0/68 (0%) | ||
Eye haemorrhage, study eye | 1/69 (1.4%) | 0/68 (0%) | ||
Lens dislocation, study eye | 0/69 (0%) | 1/68 (1.5%) | ||
Corneal perforation, fellow eye | 1/69 (1.4%) | 0/68 (0%) | ||
Infections and infestations | ||||
Acute tonsillitis | 1/69 (1.4%) | 0/68 (0%) | ||
Bronchitis | 1/69 (1.4%) | 0/68 (0%) | ||
Bronchopneumonia | 0/69 (0%) | 1/68 (1.5%) | ||
Gastroenteritis | 0/69 (0%) | 1/68 (1.5%) | ||
Pneumonia | 1/69 (1.4%) | 0/68 (0%) | ||
Pneumonia viral | 0/69 (0%) | 1/68 (1.5%) | ||
Nervous system disorders | ||||
Epilepsy | 1/69 (1.4%) | 0/68 (0%) | ||
Surgical and medical procedures | ||||
Trabeculectomy, both eyes | 1/69 (1.4%) | 0/68 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Timolol | Latanoprost | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 20/69 (29%) | 12/68 (17.6%) | ||
Eye disorders | ||||
Conjunctival disorder, both eyes | 2/69 (2.9%) | 0/68 (0%) | ||
Conjunctival hyperaemia, both eyes | 3/69 (4.3%) | 1/68 (1.5%) | ||
Conjunctival hyperaemia, study eye | 3/69 (4.3%) | 2/68 (2.9%) | ||
Visual acuity reduced, study eye | 2/69 (2.9%) | 0/68 (0%) | ||
General disorders | ||||
Pyrexia | 2/69 (2.9%) | 2/68 (2.9%) | ||
Infections and infestations | ||||
Influenza | 4/69 (5.8%) | 0/68 (0%) | ||
Nasopharyngitis | 5/69 (7.2%) | 4/68 (5.9%) | ||
Rhinitis | 1/69 (1.4%) | 2/68 (2.9%) | ||
Viral infection | 2/69 (2.9%) | 1/68 (1.5%) | ||
Nervous system disorders | ||||
Headache | 4/69 (5.8%) | 2/68 (2.9%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A6111137