CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 609 enrolled
Drug / intervention
T2380 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02101359
NCT02101359Phase 3Completed
CompareCT.gov

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

Laboratoires Thea·interventional·Posted Apr 2, 2014·Updated Nov 14, 2014

In Brief

A Phase 3 clinical trial evaluating T2380, Mydriatics, and 1 other intervention for Cataract. Completed, enrolled 609 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2014
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.3 years ago

Interventions

T2380drug

200 microlitres of T2380 will be administrated intracamerally

Mydriaticsdrug

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.

Tetracainedrug

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