Study to evaluate and compare the efficacy of local anesthetics Chloroprocaine 3% gel and Tetracaine 0.5% eye drops in cataract surgery.

Phase 1

• Conditions: cataract surgery; MedDRA version: 20.0Level: PTClassification code 10063797Term: Cataract operationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-001660-30-SK
• Lead Sponsor: Sintetica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

To be enrolled in this study, subjects must fulfil all these inclusion criteria:
1.Signed and dated informed consent
2.Male or female aged = 18 years
3.Senile or pre-senile cataract
4.Scheduled to undergo cataract surgery in a single eye at a time (clear corneal self-sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

Exclusion Criteria

Patients fulfilling at the selection visit ONE OR MORE of the following exclusion criteria will not be enrolled in the study:
Ophthalmic exclusion criteria
?Surgical conditions in the eye to be operated:
1.Combined surgery
2.Previous intraocular surgery
3.Previous corneal refractive surgeries less than 6 months before screening
?Non-surgical conditions in the eye to be operated:
4.Non Senile or non pre-senile cataract (e.g.: traumatic, pathological or congenital cataract)
5.Pupillary abnormalities (irregular, etc.)
6.Iris synechiae
7.Eye movement disorder (nystagmus, etc.)
8.Dacryocystitis and all other pathologies of tears drainage system
9.History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
10.Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
11.History of ocular traumatism, infection or inflammation within the last 3 months
12.Pseudo-exfoliation, exfoliative syndrome
13.Prior intravitreal injections within 7 days of the surgery
14. IOP over 25mmHg under treatment

?
Ophthalmic conditions in the contra-lateral eye:
15.Best corrected visual acuity < 1/10
16.Patient already included in the study for phakoexeresis
17.History of ophthalmic surgical complication (cystoid macular oedema, etc.)

Other criteria are defined in the study protocol (Systemic/non ophthalmic exclusion criteria, Specific exclusion criteria for women, Exclusion criteria related to general conditions, Exclusion criteria related to previous and concomitant medications / non-product therapies).

Study & Design

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