Trial Outcomes & Findings for Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery (NCT NCT02101359)
NCT ID: NCT02101359
Last Updated: 2014-11-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
609 participants
Primary outcome timeframe
Day 0
Results posted on
2014-11-14
Participant Flow
The patients, fulfilling the criteria for inclusion were invited to participate in the study.
Participant milestones
| Measure |
T2380
T2380: Intracameral administration during surgery
|
Reference Group
Mydriatics and anesthetics: Topical treatments used the day of surgery
|
|---|---|---|
|
Overall Study
STARTED
|
295
|
296
|
|
Overall Study
COMPLETED
|
266
|
277
|
|
Overall Study
NOT COMPLETED
|
29
|
19
|
Reasons for withdrawal
| Measure |
T2380
T2380: Intracameral administration during surgery
|
Reference Group
Mydriatics and anesthetics: Topical treatments used the day of surgery
|
|---|---|---|
|
Overall Study
Not included
|
23
|
13
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
Baseline characteristics by cohort
| Measure |
T2380
n=295 Participants
T2380: Intracameral administration during surgery
|
Reference Group
n=296 Participants
Mydriatics and anesthetic: Topical treatments used the day of surgery
|
Total
n=591 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
69.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Region of Enrollment
Algeria
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
France
|
192 participants
n=5 Participants
|
188 participants
n=7 Participants
|
380 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.
Outcome measures
| Measure |
T2380
n=268 Participants
T2380: Intracameral administration during surgery
|
Reference Group
n=281 Participants
Mydriatics and anesthetic: Topical treatments used the day of surgery
|
|---|---|---|
|
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
|
98.9 percentage of responders
|
94.7 percentage of responders
|
Adverse Events
T2380
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T2380
n=295 participants at risk
T2380: Intracameral administration during surgery
|
Reference Group
n=296 participants at risk
Mydriatics and anesthetic: Topical treatments used the day of surgery
|
|---|---|---|
|
Eye disorders
Macular oedema
|
0.34%
1/295
|
0.00%
0/296
|
|
Eye disorders
Keratitis
|
0.34%
1/295
|
0.00%
0/296
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.34%
1/295
|
0.00%
0/296
|
|
Nervous system disorders
Transient ischaemic attack
|
0.34%
1/295
|
0.00%
0/296
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/295
|
0.34%
1/296
|
|
Eye disorders
Retinal detachment
|
0.00%
0/295
|
0.34%
1/296
|
|
Eye disorders
Posterior capsule rupture
|
0.00%
0/295
|
0.34%
1/296
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.00%
0/295
|
0.34%
1/296
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/295
|
0.34%
1/296
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/295
|
0.34%
1/296
|
Other adverse events
Adverse event data not reported
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