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

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Mydriatics; Drug: T2380; Drug: Tetracaine

• Registration Number: NCT02101359
• Lead Sponsor: Laboratoires Thea

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).

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-02
• Results First Submitted: 2014-09-19
• Results First Submitted QC: 2014-09-19
• Results First Posted: 2014-09-25
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 609

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mydriatics and anesthetic	Mydriatics	Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.
T2380	T2380	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.
T2380	Tetracaine	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.
Mydriatics and anesthetic	Tetracaine	Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.	Day 0

Trial Locations

Locations (1)

Laboratoires Thea; 🇫🇷 Clermont- Ferrand, France