NCT02101359

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 40 Years – 88 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	T2380	200 microlitres of T2380 will be administrated intracamerally
DRUG	Mydriatics	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.
DRUG	Tetracaine	Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-05-01
• First posted: 2014-04-02
• Last updated: 2014-11-14
• Results posted: 2014-09-25

Locations

1 site across 1 country: France