Ocular inflammation following microincisional vitreo-retinal surgery MedDRA version: 9.1 Level: LLT Classification code 10054364 Term: Conjunctival hyperemia
Conditions
Interventions
Product Name: Netildex gel
Pharmaceutical Form: Eye gel
INN or Proposed INN: dexamethasone+netilmicin
CAS Number: 50022+563956
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equ
Sponsors
SIFI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects showing epiretinal macular membranes and having to undergo sutureless 23-25 gauge vitreoretinal surgery; 2.Able and willing to give informed consent; 3.Age between 30-70 years; 4.Any race and sex; 5.Willing and able to attend required study visits. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Recurrent anterior or posterior segment inflammation of unknown aetiology or history of inflammation and/or ocular trauma in the affected eye during the last 12 months; 2.Concomitant systemic and ocular pathologies (diabetes, ocular infections, glaucoma, ocular hypertension, severe dry-eye); 3.Patients having to undergo a combined vitreo-retinal and cataract extraction surgery; 4.Patients who underwent preceding vitreo-retinal surgeries adopting a buckling procedure; 5.Patients who underwent preceding laser or cryotherapy retinopexi; 6.Cataract surgery in the affected eye within 3 months before the beginning of the study; 7.Ocular surgery in the affected eye, other than cataract extraction, within 12 months before the beginning of the study; 8.Intraocular pressure >22 mmHg; 9.Intake of any pharmaceutical form of antibiotics, antihistamines, decongestants, steroids or non-steroidal anti-inflammatory agents within 14 days prior to study entry 10.Use of ocular medication other than artificial tears; 11.Known or suspected allergy to ocular preservatives, aminoglycosides and steroids; 12.Subjects currently participating in another clinical study or who have participated in a clinical study in the preceding 30 days; 13.Pregnant or nursing women or inadequate birth control methods (applicable to female of childbearing potential only); 14.Monophthalmic. Moreover, the following intra-operative exclusion criteria will be considered: 1.Intra-vitreal administration of triamcinolone acetonide; 2.Use of tamponating gas; 3.Need for suture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the therapeutic efficacy of a dexamethasone 0.1% and netilmicin 0.3% fixed combination ophthalmic gel in the control and treatment of post-surgical ocular inflammation, as well as in the antimicrobial prophylaxis, following sutureless microincisional (23-25 gauge ) vitreo-retinal surgery.;Secondary Objective: To assess the overall safety and the local tolerance profile of Netildex gel; to ascertain if the adopted pharmaceutical form might affect the efficacy and safety behaviour of administered actives; to know new information on a novel target population(patients who undergo vitreo-retinal surgery)evaluating the anti-inflammatory effectiveness of the investigational products.;Primary end point(s): Evaluation of the bulbar conjunctival hyperaemia, evaluated by means of slit-lamp, at Visit 4 (Day 14±2) | — |
Countries
Italy
Outcome results
None listed