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

NCT02101359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 609

Last updated 2014-11-14

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Joseph COLIN

  • Marc LABETOULLE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-01-31
Completion
2013-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101359 on ClinicalTrials.gov