Cataract
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.
Detailed description
In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).
Interventions
DRUGT2380
200 microlitres of T2380 will be administrated intracamerally
DRUGMydriatics
3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.
DRUGTetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Male or female aged from 40 to 88 years old * Scheduled to undergo unilateral cataract surgery
Exclusion criteria
* Combined surgery * Previous intraocular surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. | Day 0 |
Countries
France
Participant flow
Recruitment details
The patients, fulfilling the criteria for inclusion were invited to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| T2380 T2380: Intracameral administration during surgery | 295 |
| Reference Group Mydriatics and anesthetic: Topical treatments used the day of surgery | 296 |
| Total | 591 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Not included | 23 | 13 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Reference Group | Total | T2380 |
|---|---|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 9.2 | 69.9 years STANDARD_DEVIATION 9.3 | 69.2 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment Algeria | 31 participants | 63 participants | 32 participants |
| Region of Enrollment Austria | 10 participants | 21 participants | 11 participants |
| Region of Enrollment Belgium | 16 participants | 33 participants | 17 participants |
| Region of Enrollment France | 188 participants | 380 participants | 192 participants |
| Region of Enrollment Germany | 8 participants | 17 participants | 9 participants |
| Region of Enrollment Italy | 11 participants | 22 participants | 11 participants |
| Region of Enrollment Portugal | 12 participants | 20 participants | 8 participants |
| Region of Enrollment Spain | 11 participants | 17 participants | 6 participants |
| Region of Enrollment Sweden | 9 participants | 18 participants | 9 participants |
| Sex: Female, Male Female | 134 Participants | 254 Participants | 120 Participants |
| Sex: Female, Male Male | 162 Participants | 337 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 295 | 0 / 296 |
| serious Total, serious adverse events | 4 / 295 | 6 / 296 |
Outcome results
Primary
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
Time frame: Day 0
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T2380 | 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 |
| Reference Group | The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. | 94.7 percentage of responders |