Phase IV, open-label, randomized clinical trial to evaluate the effects of Fydrane® and standard topical mydriatics and anaesthetics protocol on ocular surface after cataract surgery. - EFOS

aboratoires Théa0 sites50 target enrollmentNovember 22, 2017

ConditionsCataracts MedDRA version: 20.0 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10063797 Term: Cataract operation System Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

DrugsFydrane Colircusi Anestésico Doble

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cataracts
Sponsor: aboratoires Théa
Enrollment: 50
Status: Active, Not Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 22, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

aboratoires Théa

Eligibility Criteria

Inclusion Criteria

•1\. Male or female patient aged 40 to 88 years, scheduled to undergo bilateral cataract surgery within the next 17 days (under topical anaesthesia and using clear corneal self\-sealing incisions \-phacoemulsification\- foldable intraocular lens surgery with injector).
•2\. Pupil diameter \=7 mm at selection visit after the following dilatation protocol: 1 drop of tropicamide 1% \+ 1 drop of phenylephrine 10%, with a maximum of 3 combined instillations at 10\-minute intervals (i.e. time 0 minutes, time 0 \+ 10 minutes, and time 0 \+ 20 minutes), if necessary.
•3\. Scheduled use of intraocular lens injector Monarch II during the bilateral cataract surgery.
•4\. Patient willing and able to provide written informed consent prior to any study\-related procedure and to comply with all study requirements.
•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 15
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 35

Exclusion Criteria

•1\. Patient who have combined surgery; previous intraocular and/or corneal surgery; iatrogenic, traumatic or congenital cataract; pupillary abnormalities (e.g. irregular); iris synechiae; eye movement disorder (e.g. nystagmus); dacryocystitis and all other pathologies of tear drainage system; history of inflammatory ocular disease (e.g. iritis, uveitis, herpetic keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); corneal, epithelial, stromal or endothelial residual or evolutionary disease (including corneal ulceration and superficial punctate keratitis); history of ocular traumatism, infection or inflammation within the last 3 months; pseudoexfoliation, exfoliative syndrome; in any eye.
•2\. Clinically significant ocular endothelial dysfunction.
•3\. Patients with a cataract hardness in one of the eyes and/or grade \=3 as per the Lens Opacities Classification System III (LOCS III).
•4\. The following concomitant medications will not be allowed: systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery; systemic opioids and morphinic drugs within 7 days before surgery, topical ocular treatment with mydriatic and/or anaesthetic action within 7 days before surgery; other systemic analgesics (except paracetamol) within 7 days before surgery; contact lenses within 7 days before surgery; topical treatment with anti\-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol); anxiolytics and hypnotics on
•the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution.
•5\. Any known ocular disorders affecting eye surface (i.e. staining grade \>1 as per the Oxford schema).
•6\. Known hypersensitivity to the active substances (tropicamide, phenylephrine, lidocaine, oxybuprocain or tetracaine), any of their excipients, anaesthetics of the amide type or atropine derivatives.
•7\. Pregnancy or breastfeeding, in women of childbearing potential (i.e. fertile, following menarche and until becoming post\-menopausal unless permanently sterile).