Trial Outcomes & Findings for Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients (NCT NCT01652664)
NCT ID: NCT01652664
Last Updated: 2015-07-23
Results Overview
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
Baseline (Day 0), Month 3
Results posted on
2015-07-23
Participant Flow
Participants were recruited from 38 investigational centers in the United States, Germany, Singapore, United Kingdom, Taiwan, Philippines, Spain, Saudi Arabia, Colombia, France, Portugal, Belgium, Poland, Romania, Puerto Rico, and Mexico.
Of the 184 enrolled, 32 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (152).
Participant milestones
| Measure |
Travoprost
1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
|
Timolol
1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
|
Overall Study
COMPLETED
|
71
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Travoprost
1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
|
Timolol
1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
|---|---|---|
|
Overall Study
Treatment Failure
|
5
|
1
|
|
Overall Study
Inadequate IOP control
|
1
|
0
|
Baseline Characteristics
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Baseline characteristics by cohort
| Measure |
Travoprost
n=77 Participants
1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
|
Timolol
n=75 Participants
1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 months to <3 years
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
3 to <12 years
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Age, Customized
12 to <18 years
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Intraocular Pressure
|
24.7 mmHg
STANDARD_DEVIATION 4.62 • n=5 Participants
|
24.2 mmHg
STANDARD_DEVIATION 4.01 • n=7 Participants
|
24.4 mmHg
STANDARD_DEVIATION 4.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Month 3Population: All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.
IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
Outcome measures
| Measure |
Travoprost
n=71 Participants
1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
|
Timolol
n=74 Participants
1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
|---|---|---|
|
Mean Change From Baseline in IOP at Month 3
|
-5.4 mmHg
Standard Error 0.98
|
-5.3 mmHg
Standard Error 0.93
|
Adverse Events
Pre-Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Travoprost
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Timolol
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Treatment
n=184 participants at risk
All enrolled participants
|
Travoprost
n=77 participants at risk
All participants who received travoprost with vehicle
|
Timolol
n=75 participants at risk
All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
|---|---|---|---|
|
Infections and infestations
Keratitis bacterial
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
1.3%
1/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
1.3%
1/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Infections and infestations
Viral infection
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
1.3%
1/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
Pre-Treatment
n=184 participants at risk
All enrolled participants
|
Travoprost
n=77 participants at risk
All participants who received travoprost with vehicle
|
Timolol
n=75 participants at risk
All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
|
|---|---|---|---|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
19.5%
15/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
4.0%
3/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Eye disorders
Growth of eyelashes
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
6.5%
5/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
0.00%
0/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
5.2%
4/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
1.3%
1/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
|
Nervous system disorders
Headache
|
0.54%
1/184 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
6.5%
5/77 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
2.7%
2/75 • Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
|
Additional Information
Subha Venkataraman, Clinical Project Lead
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER