Trial Outcomes & Findings for Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients (NCT NCT03825380)
NCT ID: NCT03825380
Last Updated: 2023-11-21
Results Overview
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
485 participants
Primary outcome timeframe
Week 12
Results posted on
2023-11-21
Participant Flow
485 patients (from 723 screened patients) were included and randomised in the study: 485 patients in the intent-to-treat (ITT) set and Safety set, 469 in the modified ITT (mITT) set. The recruitment started on 23-NOV-2018 and was completed on 28-AUG-2020 and the last patient completed the study on 24-FEB-2021.
Incl/Excl criteria checked at screening visit, then patients discontinued their current treatment to start the run-in period with Azopt, for 5 weeks. The Azopt was stopped 1 or 2 weeks before the randomisation visit (Day 1). Incl/Excl criteria are confirmed at Day 1. 723 screened patients, 485 randomised patients, 238 screen failure patients.
Participant milestones
| Measure |
T4032
Bimatoprost: Eyedrops
|
Lumigan®
Lumigan®: Eyedrops
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
249
|
|
Overall Study
COMPLETED
|
218
|
227
|
|
Overall Study
NOT COMPLETED
|
18
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
T4032
n=236 Participants
Bimatoprost: Eyedrops
|
Lumigan®
n=249 Participants
Lumigan®: Eyedrops
|
Total
n=485 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=236 Participants
|
0 Participants
n=249 Participants
|
0 Participants
n=485 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=236 Participants
|
125 Participants
n=249 Participants
|
251 Participants
n=485 Participants
|
|
Age, Categorical
>=65 years
|
110 Participants
n=236 Participants
|
124 Participants
n=249 Participants
|
234 Participants
n=485 Participants
|
|
Age, Continuous
|
63.03 years
STANDARD_DEVIATION 11.85 • n=236 Participants
|
63.67 years
STANDARD_DEVIATION 10.92 • n=249 Participants
|
63.36 years
STANDARD_DEVIATION 11.38 • n=485 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=236 Participants
|
153 Participants
n=249 Participants
|
294 Participants
n=485 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=236 Participants
|
96 Participants
n=249 Participants
|
191 Participants
n=485 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Estonia
|
6 participants
n=236 Participants
|
8 participants
n=249 Participants
|
14 participants
n=485 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=236 Participants
|
3 participants
n=249 Participants
|
8 participants
n=485 Participants
|
|
Region of Enrollment
Bulgaria
|
41 participants
n=236 Participants
|
39 participants
n=249 Participants
|
80 participants
n=485 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=236 Participants
|
3 participants
n=249 Participants
|
7 participants
n=485 Participants
|
|
Region of Enrollment
Czechia
|
21 participants
n=236 Participants
|
19 participants
n=249 Participants
|
40 participants
n=485 Participants
|
|
Region of Enrollment
France
|
10 participants
n=236 Participants
|
13 participants
n=249 Participants
|
23 participants
n=485 Participants
|
|
Region of Enrollment
Georgia
|
5 participants
n=236 Participants
|
7 participants
n=249 Participants
|
12 participants
n=485 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=236 Participants
|
4 participants
n=249 Participants
|
8 participants
n=485 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=236 Participants
|
9 participants
n=249 Participants
|
13 participants
n=485 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=236 Participants
|
0 participants
n=249 Participants
|
2 participants
n=485 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=236 Participants
|
12 participants
n=249 Participants
|
25 participants
n=485 Participants
|
|
Region of Enrollment
Latvia
|
9 participants
n=236 Participants
|
11 participants
n=249 Participants
|
20 participants
n=485 Participants
|
|
Region of Enrollment
Lithuania
|
4 participants
n=236 Participants
|
3 participants
n=249 Participants
|
7 participants
n=485 Participants
|
|
Region of Enrollment
Mauritius
|
1 participants
n=236 Participants
|
0 participants
n=249 Participants
|
1 participants
n=485 Participants
|
|
Region of Enrollment
Poland
|
20 participants
n=236 Participants
|
27 participants
n=249 Participants
|
47 participants
n=485 Participants
|
|
Region of Enrollment
Russia
|
30 participants
n=236 Participants
|
31 participants
n=249 Participants
|
61 participants
n=485 Participants
|
|
Region of Enrollment
Slovakia
|
10 participants
n=236 Participants
|
12 participants
n=249 Participants
|
22 participants
n=485 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=236 Participants
|
14 participants
n=249 Participants
|
28 participants
n=485 Participants
|
|
Region of Enrollment
Tunisia
|
17 participants
n=236 Participants
|
19 participants
n=249 Participants
|
36 participants
n=485 Participants
|
|
Region of Enrollment
Ukraine
|
16 participants
n=236 Participants
|
14 participants
n=249 Participants
|
30 participants
n=485 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=236 Participants
|
1 participants
n=249 Participants
|
1 participants
n=485 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Modified Intent To Treat
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
Outcome measures
| Measure |
T4032
n=229 Participants
Bimatoprost: Eyedrops
|
Lumigan®
n=240 Participants
Lumigan®: Eyedrops
|
|---|---|---|
|
Intra-Ocular Pressure
|
-9.67 mmHg
Standard Error 0.19
|
-9.50 mmHg
Standard Error 0.18
|
Adverse Events
T4032
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Lumigan®
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T4032
n=236 participants at risk
Bimatoprost: Eyedrops
|
Lumigan®
n=249 participants at risk
Lumigan®: Eyedrops
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.42%
1/236 • Number of events 1 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
0.00%
0/249 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/236 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
0.40%
1/249 • Number of events 1 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/236 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
0.40%
1/249 • Number of events 1 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
Other adverse events
| Measure |
T4032
n=236 participants at risk
Bimatoprost: Eyedrops
|
Lumigan®
n=249 participants at risk
Lumigan®: Eyedrops
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
5.5%
13/236 • Number of events 13 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
6.8%
17/249 • Number of events 17 • Adverse event reporting extends from start of the treatment until Day 112 follow-up phone call.
|
Additional Information
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