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

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ClinicalTrials.gov Identifier: NCT02973880
Recruitment Status : Not yet recruiting
First Posted : November 25, 2016
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Sintesi Research Srl
Information provided by (Responsible Party):
SIFI SpA

Brief 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.


Condition or disease Intervention/treatment Phase
Cataract Extraction Cataract Drug: NETILDEX™ ophthalmic gel Drug: NETILDEX™ eye drops solution Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two treatment arms, test group versus active-comparator (control) group, treated in parallel.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All daily study products will be manufactured in indistinguishable single dose plastic vials, labeled in accordance with hour of administration. In accordance with the double-blind design of the study, daily treatment for patients randomized to group A (NETILDEX™ ophthalmic gel), will be of 2 doses of active treatment and 2 doses of indistinguishable placebo. For blinding purposes, Group B (NETILDEX™ eye drops solution) medications labels will consist in an aluminum envelope for each dose of the daily treatment, containing indistinguishable plastic vials of NETILDEX™ eye drops solution. Tertiary packaging (patient's treatment supply) will be a carton box appropriately labeled, containing 16 secondary packages (aluminum envelopes - each envelope containing 5 vials for each treatment time dose), containing enough plastic vials to allow the patient to complete the whole study treatment.
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Controlled, Double-blind Study to Evaluate the Efficacy and Tolerability of a Steroid/Antibiotic Associated Treatment Following Cataract Extraction by Means of Phaco-emulsification
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Cataract

Arm Intervention/treatment
Experimental: NETILDEX™ ophthalmic gel

1 drop of NETILDEX™ (Netilmicine 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™ ophthalmic gel
Active Comparator: NETILDEX™ eye drops solution

1 drop of NETILDEX™ (Netilmicine 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.

Drug: NETILDEX™ eye drops solution



Primary Outcome Measures :
  1. Measurement of inflammation conditions in the anterior ocular chamber after cataract extraction through Slit Lamp and Bio-microscopy. [ Time Frame: Throughout study completion, approximately 9 weeks. ]
    The measurement aims to demonstrate the efficacy of a reduced frequency of administration of NETILDEX™ ophthalmic gel, administered twice daily (b.i.d.), in comparison with NETILDEX™ eye drops solution, administered four times a day (q.i.d.), in the prevention of post-surgery inflammation after cataract extraction by means of phaco-emulsification.


Secondary Outcome Measures :
  1. Evaluation of antibiotic efficacy based on the presence of detected microbial infections (positive ocular swabs and anti-biogram results, if any). [ Time Frame: Within 24 hours after cataract surgery. ]
    The anti-biogram should be performed according to standard procedure at investigational sites, but including at least the test with Netilmicin and Cefuroxime.

  2. Assessment of a potential variation in the intra-ocular pressure related to the use of the gel formulation compared to the eye-drops formulation, through its measurement before and after treatment. [ Time Frame: Throughout study completion, approximately 9 weeks. ]
  3. Evaluation of clinical signs and symptoms of ocular inflammation (other than flare and cellularity) through standard scoring systems. [ Time Frame: Throughout study completion, approximately 9 weeks. ]
    In particular, attention will be focused on the evaluation in treated Patients of: the degree of conjunctival hyperemia; lid/corneal edema; ocular discomfort.

  4. Evaluation of visual acuity through standard measurement systems. [ Time Frame: Throughout study completion, approximately 9 weeks. ]
  5. Evaluation of the global tolerability of NETILDEX™ ophthalmic gel in treated Patients (by the Investigator), through a standard questionnaire. [ Time Frame: Within 2 weeks after cataract surgery. ]
  6. Evaluation of the safety of NETILDEX™ ophthalmic gel through the collection and evaluation of adverse events. [ Time Frame: Throughout study completion, approximately 9 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Patients with medical history of ocular inflammation diseases, Herpes infections, iritis, uveitis or Sjogren's syndrome;
  2. Patients who have been treated for external ocular infections within a month before the study enrolment (V1);
  3. Patients with cellularity in the anterior ocular chamber ≥ grade 2 (16-25 cells / field 1x1 mm);
  4. Patients with flare in the anterior ocular chamber ≥ grade 2 (moderate);
  5. 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);
  6. Patients with PEX Syndrome (Pseudo-exfoliation syndrome);
  7. Patients with poor mydriasis, basing on Investigator's judgment;
  8. Patients with intra-ocular pressure > 24 mmHg;
  9. Patients who have undergone surgery in the eye involved in the cataract extraction within the 12 months before the study enrolment (V1);
  10. Patients who have received corneal laser treatment in the eye involved in the cataract extraction within the 6 months before the study enrolment (V1);
  11. Patients with known or suspected allergy or hypersensitivity to ophthalmic preservatives, phenylacetic acid derivatives, aminoglycosides, Bromfenac, other NSAIDs, steroids;
  12. Patients with traumatic cataract condition;
  13. Patients who have been treated or are under treatment with alpha-blocking agents for more than 3 months before the study enrolment (V1);
  14. Patients who have received treatment with anti-histamines, decongestants, antiinflammatory steroidal or non-steroidal (NSAID) drugs within the 15 days before the study enrolment (V1);
  15. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment (V1);
  16. Patients receiving any ocular treatment, with the exception of artificial tears;
  17. Female Patients who are pregnant or breast-feeding;
  18. Female Patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception*;
  19. Monocle Patients;
  20. 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: implants, injectables, some intra-uterine devices, condoms, abstinence or vasectomized partner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973880


Contacts
Contact: Aldo Caporossi, MD, Prof. 00390630155228 aldo.caporossi@unicatt.it
Contact: Anna Rita Blanco, Dr. 00390957922201 rita.blanco@sifigroup.com

Locations
Germany
Klinikum Ernst von Bergmann Ophthalmologie Not yet recruiting
Potsdam, Germany, 14467
Contact: Anja Liekfeld, MD, Prof.    00493312415101    aliekfeld@klinikumevb.de   
Contact: Silvia Zarmas-Roehl, MD    00491739596666    szarmas@klinikumevb.de   
Principal Investigator: Anja Liekfeld, MD, Prof.         
Sub-Investigator: Silvia Zarmas-Roehl, MD         
Augenklinik und Poliklinik Ophthalmologie Not yet recruiting
Wurzburg, Germany, 87080
Contact: Thomas Ach, MD    004993120120458    ach_t@ukw.de   
Contact: Daniel Kampik, MD    004993120120627    kampik_d@ukw.de   
Principal Investigator: Thomas Ach, MD         
Sub-Investigator: Daniel Kampik, MD         
Italy
Azienda Ospedaliero-Universitaria Careggi Not yet recruiting
Firenze, Italy, 50134
Contact: Rita Mencucci, MD    0039055411765    rita.mencucci@unifi.it   
Contact: Eleonora Favuzza, MD    00393288151559    elefavuzza@virgilio.it   
Principal Investigator: Rita Mencucci, MD         
Sub-Investigator: Eleonora Favuzza, MD         
Azienda Ospedaliera Fatebenefratelli e Oftalmico Not yet recruiting
Milano, Italy, 20121
Contact: Antonio Scialdone, MD, Prof.    00390263632754    antonio.scialdone@asst-fbf-sacco.it   
Contact: Francesco De Gaetano, MD    00393397147220    fradega1975@yahoo.it   
Principal Investigator: Antonio Scialdone, MD, Prof.         
Sub-Investigator: Francesco De Gaetano, MD         
Policlinico Universitario A. Gemelli Not yet recruiting
Roma, Italy, 00168
Contact: Aldo Caporossi, MD, Prof.    00390630155228    aldo.caporossi@unicatt.it   
Contact: Antonio Villano, MD    00393392410616    antonio.villano.md@gmail.com   
Principal Investigator: Aldo Caporossi, MD, Prof.         
Sub-Investigator: Antonio Villano, MD         
Romania
Centrul Medical Unirea Not yet recruiting
Bucuresti, Romania, 010576
Contact: Sinziana Gradinaru, MD    00407256535515    sinziana.gradinaru@reginamaria.ro   
Contact: Ruxandra Tudosescu, MD         
Principal Investigator: Sinziana Gradinaru, MD         
Sub-Investigator: Ruxandra Tudosescu, MD         
Spitalul Universitar de Urgenta Bucuresti Not yet recruiting
Bucuresti, Romania, 050098
Contact: Liliana Voinea, MD, Prof.    0040785205632    voineamliliana@yahoo.com   
Contact: Radu Ciuluvica, MD         
Principal Investigator: Liliana Voinea, MD, Prof.         
Sub-Investigator: Radu Ciuluvica, MD         
Spitalul Universitar de Urgenta Bucuresti Not yet recruiting
Bucuresti, Romania, 050098
Contact: Alina P Cherecheanu, MD    0040723507047    alina_cherecheanu@yahoo.com   
Contact: Aurelian M Ghita, MD         
Principal Investigator: Alina P Cherecheanu, MD         
Sub-Investigator: Aurelian M Ghita, MD         
Sponsors and Collaborators
SIFI SpA
Sintesi Research Srl
Investigators
Principal Investigator: Aldo Caporossi, MD, Prof. Policlinico Universitario A. Gemelli

Publications:
Barry P, Cordovés L, Gardner S. ESCRS Guidelines for Prevention and Treatment of Endophthalmitis Following Cataract Surgery: Data, Dilemmas and Conclusions. The European Society for Cataract & Refractive Surgeons 2013

Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02973880     History of Changes
Other Study ID Numbers: 044-SI
2016-002138-63 ( EudraCT Number )
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SIFI SpA:
Steroid/antibiotic associated treatment
Phaco-emulsification
Cataract extraction

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Pharmaceutical Solutions
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ophthalmic Solutions
Anti-Infective Agents
Antitubercular Agents