Trial Outcomes & Findings for Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension (NCT NCT01494753)
NCT ID: NCT01494753
Last Updated: 2024-02-07
Results Overview
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
COMPLETED
PHASE2
30 participants
Day 42 and Day 84 (8.00am for the IOP)
2024-02-07
Participant Flow
Participant milestones
| Measure |
Prostaglandin/T2345
One drop at 8.00pm.
|
T2345/Prostaglandin
One drop at 8.00pm.
|
|---|---|---|
|
Day0-Day42
STARTED
|
15
|
15
|
|
Day0-Day42
COMPLETED
|
15
|
15
|
|
Day0-Day42
NOT COMPLETED
|
0
|
0
|
|
Day42-Day84
STARTED
|
15
|
15
|
|
Day42-Day84
COMPLETED
|
15
|
15
|
|
Day42-Day84
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Prostaglandin/T2345
n=15 Participants
One drop at 8.00pm.
|
T2345/Prostaglandin
n=15 Participants
One drop at 8.00pm.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42 and Day 84 (8.00am for the IOP)Population: Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
Outcome measures
| Measure |
Prostaglandin/T2345
n=15 Participants
One drop at 8.00pm.
|
T2345/Prostaglandin
n=15 Participants
One drop at 8.00pm.
|
|---|---|---|
|
Mean Intra Ocular Pressure (IOP) at 8.00am
IOP at 8am for the worse eye (PPset) D42
|
16.6 mmHg
Standard Deviation 3
|
16.3 mmHg
Standard Deviation 2.3
|
|
Mean Intra Ocular Pressure (IOP) at 8.00am
IOP at 8am for the worse eye (PPset) D84
|
17 mmHg
Standard Deviation 2.2
|
15.7 mmHg
Standard Deviation 2.9
|
Adverse Events
Prostaglandin
T2345
Serious adverse events
| Measure |
Prostaglandin
n=30 participants at risk
One drop at 8.00pm.
|
T2345
n=30 participants at risk
One drop at 8.00pm.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/30
|
3.3%
1/30
|
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