Efficacy and safety assessment of an injectable solution containing the three active substances in the same vial (tropicamide, phenylephrine for mydriatic effect and lidocaine for anaesthesia) used for cataract surgery.

Phase 1

• Conditions: The aim of this clinical study will be to develop a combination of active substances enabling to obtain at the same time a mydriasis and an anaesthesia during cataract surgery.; MedDRA version: 14.1Level: PTClassification code 10011719Term: CycloplegiaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10028521Term: MydriasisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-021188-34-BE
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-06
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

-Signed and dated informed consent
-Male or female aged from 40 to 88 years old
-Scheduled to undergo unilateral cataract surgery
-Pupil diameter = 7 mm at selection visit after dilatation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Surgical conditions in the eye to be operated:
-Combined surgery
-Previous intraocular surgery
Non-surgical conditions in the eye to be operated:
- Iatrogenic or traumatic or congenital cataract.
-Pupillary abnormalities (irregular,..)
-Very dark iris
-Iris synechiae
-Eye movement disorder (Nystagmus,..)
-Dacryocystitis and all others pathologies of tears drainage system
-History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis,…)
-Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
-History of ocular traumatism, infection or inflammation within the last 3 months
-Pseudoexfoliation, exfoliative syndrome,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified