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Completed

NCT Number: NCT02101359

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratoires Thea

Clermont-Ferrand, 63430, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T2380

Drug

200 microlitres of T2380 will be administrated intracamerally

Mydriatics

Drug

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.

Other names: Tropicamide, Phenylpehrine

Tetracaine

Drug

Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Other names: Tetracaine 1%

Primary outcomes

  1. The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2014
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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