Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction

PHASE3CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 15, 2017

Primary Completion Date

December 1, 2018

Study Completion Date

December 30, 2018

Conditions
Cataract ExtractionCataract
Interventions
DRUG

NETILDEX™ ophthalmic gel

"1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery."

DRUG

NETILDEX™ eye drops solution

"1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery."

Trial Locations (7)

14467

Klinikum Ernst von Bergmann Ophthalmologie, Potsdam

20121

Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milan

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

87080

Augenklinik und Poliklinik Ophthalmologie, Würzburg

00168

Policlinico Universitario A. Gemelli, Roma

010576

Centrul Medical Unirea, Bucharest

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

All Listed Sponsors
collaborator

Sintesi Research Srl

INDUSTRY

lead

SIFI SpA

INDUSTRY

NCT02973880 - Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction | Biotech Hunter | Biotech Hunter