Trial Outcomes & Findings for Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients (NCT NCT01156012)
NCT ID: NCT01156012
Last Updated: 2015-01-22
Results Overview
The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.
COMPLETED
PHASE3
404 participants
Day 0 and Day 84
2015-01-22
Participant Flow
Included patients= 404 patients but 2 patients without available data after Day 0. These 2 patients were excluded from the analyses sets.
Participant milestones
| Measure |
T2345
One drop of T2345
T2345: One drop of T2345 at 9.00pm
|
Prostaglandin
One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
189
|
|
Overall Study
COMPLETED
|
206
|
186
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
T2345
One drop of T2345
T2345: One drop of T2345 at 9.00pm
|
Prostaglandin
One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
use of commercial drug instead of study
|
0
|
1
|
|
Overall Study
Non respect of one of inclusion criteria
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Baseline characteristics by cohort
| Measure |
T2345
n=213 Participants
One drop of T2345
T2345: One drop of T2345 at 9.00pm.
|
Prostaglandin
n=189 Participants
One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
104 participants
n=5 Participants
|
93 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
47 participants
n=5 Participants
|
44 participants
n=7 Participants
|
91 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 84Population: mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.
The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.
Outcome measures
| Measure |
T2345
n=189 Participants
One drop of T2345
T2345: One drop of T2345 at 9.00pm.
|
Prostaglandin
n=164 Participants
One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP)
|
-8.6 mmHg
Standard Deviation 2.6
|
-9.0 mmHg
Standard Deviation 2.4
|
Adverse Events
T2345
Prostaglandin
Serious adverse events
| Measure |
T2345
n=213 participants at risk
One drop of T2345
T2345: One drop of T2345 at 9.00pm.
|
Prostaglandin
n=189 participants at risk
One drop of prostaglandin
Prostaglandin: One drop of prostaglandin at 9.00pm
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.47%
1/213 • Number of events 1
|
0.00%
0/189
|
|
Psychiatric disorders
Major depression
|
0.47%
1/213 • Number of events 1
|
0.00%
0/189
|
|
Nervous system disorders
Syncope
|
0.47%
1/213 • Number of events 1
|
0.00%
0/189
|
|
General disorders
Chest pain
|
0.47%
1/213 • Number of events 1
|
0.00%
0/189
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.47%
1/213 • Number of events 1
|
0.00%
0/189
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/213
|
0.53%
1/189 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Pascale Pouliquen - Medical Director
Laboratoires Théa
Results disclosure agreements
- Principal investigator is a sponsor employee All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
- Publication restrictions are in place
Restriction type: OTHER