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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00716859
Collaborator
(none)
139
48
2
16
2.9
0.2

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

Study Type:
Interventional
Actual Enrollment :
139 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

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

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

Ages Eligible for Study:
36 Weeks to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00716859
Other Study ID Numbers:
  • A6111137
First Posted:
Jul 16, 2008
Last Update Posted:
Feb 3, 2021
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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
3. Secondary Outcome
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
4. Secondary Outcome
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
5. Secondary Outcome
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)
6. Secondary Outcome
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)
7. Secondary Outcome
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)
8. Secondary Outcome
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)
9. Secondary Outcome
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).
10. Secondary Outcome
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

[Not Specified]

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00716859
Other Study ID Numbers:
  • A6111137
First Posted:
Jul 16, 2008
Last Update Posted:
Feb 3, 2021
Last Verified:
Jan 1, 2011