Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)

Conditions
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Cataract

Intervention / Treatment
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* Drug: T2380
* Drug: Mydriatics
* Drug: Tetracaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T2380<br>Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. At the beginning of surgery, 200 μL of T2380 were administrated intracamerally. | Drug: T2380<br>* 200 microlitres of T2380 will be administrated intracamerally<br>Drug: Tetracaine<br>* Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery<br>* Other names: Tetracaine 1%;|
| Active Comparator: Mydriatics and anesthetic<br>Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery. | Drug: Mydriatics<br>* 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.<br>* Other names: Tropicamide, Phenylpehrine;Drug: Tetracaine<br>* Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery<br>* Other names: Tetracaine 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. |  | Day 0 |