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

NCT02101359 | Completed Phase 3 Results

• 1 other identifier: LT2380-PIII-05/10
• Study Type: interventional
• Target: 609
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

  Day 0

Study Arms (2)

T2380

EXPERIMENTAL

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; Drug: Tetracaine

Mydriatics and anesthetic

ACTIVE COMPARATOR

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

Drug: Mydriatics; Drug: Tetracaine

Interventions

T2380 DRUG

200 microlitres of T2380 will be administrated intracamerally

T2380

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.

Also known as: Tropicamide, Phenylpehrine

Mydriatics and anesthetic

Tetracaine DRUG

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

Also known as: Tetracaine 1%

Mydriatics and anesthetic; T2380

Eligibility Criteria

• Age: 40 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent
• Male or female aged from 40 to 88 years old
• Scheduled to undergo unilateral cataract surgery

You may not qualify if:

• Combined surgery
• Previous intraocular surgery

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Laboratoires Thea

Clermont-Ferrand, 63430, France

Location

Related Publications (2)

• 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.

  PMID: 32126990 DERIVED

• 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.

  PMID: 26531052 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Mydriatics; Tropicamide; Tetracaine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Medical director
• Organization: Laboratoires Thea

p.pouliquen@laboratoires-thea.fr

33-4-73-98-14-36

Study Officials

• Joseph COLIN

  PRINCIPAL INVESTIGATOR

• Marc LABETOULLE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: April 2, 2014
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 14, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-11

Locations

FR (1)