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

November 4, 2014 updated by: Laboratoires Thea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

609

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont- Ferrand, France, 63430
        • Laboratoires Thea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: T2380
200 microlitres of T2380 will be administrated intracamerally
Drug: Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Other Names:
  • Tetracaine 1%
Active Comparator: Mydriatics and anesthetic

Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery.

Topical Mydriatic treatments were instilled three times before surgery.
Drug: Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Other Names:
  • Tetracaine 1%
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.
Other Names:
  • Tropicamide, Phenylpehrine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Joseph COLIN
  • Principal Investigator: Marc LABETOULLE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2380-PIII-05/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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