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

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success.

Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation.

After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative.

NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time.

The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SIFI SpA
• Collaborator: Sintesi Research Srl
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ophthalmic Solutions; Pharmaceutical Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

1. Male or female Patients

2. Patients aged ≥ 40 years old

3. Patients undergoing cataract extraction surgery through phaco-emulsification and intra-ocular lens implantation

4. Patients with grade 2 or 3 according to LOCS III system for grading age-related cataract

5. Patients with transparent cornea (endothelial count in the limits for age but not lower than 1200 cells/mm2)

6. Patients understanding the nature of the study and providing their informed consent to participation

7. Patients willing and able to attend the visits and procedures foreseen by study protocol

8. Patients with negative Amsler Test at enrolment visit (V1)

Exclusion Criteria:

• Patients with medical history of ocular inflammation diseases, Herpes infections, iritis, uveitis or Sjogren's syndrome

• Patients who have been treated for external ocular infections within a month before the study enrolment (V1)

• Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm)

• Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate)

• Patients with at least one of the following concomitant ocular diseases: ocular infections, uveitis, iritis, iridociclitis, glaucoma, diabetic retinopathy, diabetes, maculopathy, shallow anterior chamber (based on Investigator's judgment)

• Patients with PEX Syndrome (Pseudo-exfoliation syndrome)

• Patients with poor mydriasis, basing on Investigator's judgment

• Patients with intra-ocular pressure > 24 mmHg

• Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1)

• Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1)

• Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids

• Patients with traumatic cataract condition

• Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1)

• Patients who have received treatment with anti-histamines, decongestants, anti-inflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1). Bromfenac, only, will be allowed for 3 days before cataract surgery

• Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1)

• Patients receiving any ocular treatment, with the exception of artificial tears

• Female Patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later

• Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception *

• Monocle Patients

• Patients with epiretinal membrane as per OCT test at enrolment visit (V1)

• Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices, abstinence or vasectomized partner. Contraception should be maintained until treatment discontinuation.