Back to results

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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

T2380

Mydriatics

Tetracaine

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laboratoires Thea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T2380

Mydriatics and anesthetic

Arm Description

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.

Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02101359

First Posted

September 4, 2013

Last Updated

November 4, 2014

Sponsor

Laboratoires Thea

1. Study Identification

Unique Protocol Identification Number

NCT02101359

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires Thea

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

609 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T2380

Arm Type

Experimental

Arm Description

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.

Arm Title

Mydriatics and anesthetic

Arm Type

Active Comparator

Arm Description

Topical anaesthetic: Tetracaine was instilled in the eye to be operated before surgery. Topical Mydriatic treatments were instilled three times before surgery.

Intervention Type

Drug

Intervention Name(s)

T2380

Intervention Description

200 microlitres of T2380 will be administrated intracamerally

Intervention Type

Drug

Intervention Name(s)

Mydriatics

Other Intervention Name(s)

Tropicamide, Phenylpehrine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tetracaine

Other Intervention Name(s)

Tetracaine 1%

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph COLIN

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc LABETOULLE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratoires Thea

City

Clermont- Ferrand

ZIP/Postal Code

63430

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

32126990

Citation

Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.

Results Reference

derived

PubMed Identifier

26531052

Citation

Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs