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NCT02101359 Clinical Trial

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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02101359
Other study ID # LT2380-PIII-05/10
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2013
Last updated November 4, 2014
Start date June 2011
Est. completion date May 2013

Study information
Verified date November 2014
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeSpain: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSweden: Medical Products AgencyAlgeria: Ministry of HealthAustria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 609
Est. completion date May 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 88 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• T2380
200 microlitres of T2380 will be administrated intracamerally
• 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.
• Tetracaine
Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery

Locations
Country Name City State
France Laboratoires Thea Clermont- Ferrand

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment. Day 0 No
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