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Trial record 36 of 52 for:    cataract AND ophthalmic suspension

Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery (LEADER7)

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ClinicalTrials.gov Identifier: NCT03739528
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
NTC srl

Brief Summary:
The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

Condition or disease Intervention/treatment Phase
Cataract Drug: Levofloxacin + dexamethasone followed by dexamethasone Drug: Tobramycin + Dexamethasone Phase 3

Detailed Description:

In clinical practice, topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation.

The combination of tobramycin and dexamethasone is among the most widely used combinations, however, treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.

The aim of this study is to evaluate the non-inferiority of the study treatment, used for a limited period of time and followed by dexamethasone alone, compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, parallel-group study
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An International, Multicenter, Randomized, Blinded-assessor, Parallel-group Clinical Study Comparing Eye Drops of Combined LEvofloxAcin + DExamethasone foR 7 Days Followed by Dexamethasone Alone for an Additional 7 Days vs. Tobramycin + Dexamethasone for 14 Days for the Prevention and Treatment of Inflammation and Prevention of Infection Associated With Cataract Surgery in Adults - LEADER 7
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Experimental: Levofloxacin + Dexamethasone followed by dexamethasone
Levofloxacin 5 mg/ml+Dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day).
Drug: Levofloxacin + dexamethasone followed by dexamethasone
Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day.
Other Name: Levofloxacin + dexamethasone followed by Maxidex

Active Comparator: Tobramycin + dexamethasone
Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).
Drug: Tobramycin + Dexamethasone
Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
Other Name: Tobradex




Primary Outcome Measures :
  1. Proportion of patients without signs of anterior chamber inflammation [ Time Frame: After 14 days of treatment ]
    The proportion of patients without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses will be tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS > - Δ. Where πT and πS are the proportions of patients without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.


Secondary Outcome Measures :
  1. Incidence of endophthalmitis [ Time Frame: After 3, 7 and 14 days of treatment ]
    The proportion of diagnoses of endophthalmitis after administration of study treatment in the study will be assessed and reported. Diagnosis of endophthalmitis is based on clinical evaluation of signs and symptoms (such as swollen eyelids, ocular pain, conjunctival hyperemia, decreased visual acuity, opaque vitreous) through slit lamp examination, and microbiological tests on conjunctival or corneal swabs.

  2. Proportion of patients without signs of anterior ocular chamber inflammation [ Time Frame: After 3 and 7 days of treatment ]
    The proportion of patients without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses will be tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS > - Δ. Where πT and πS are the proportions of patients without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.

  3. Conjunctival hyperemia [ Time Frame: After 3, 7 and 14 days of treatment ]
    Conjunctival hyperemia will be evaluated with slit lamp and results provided as a score as follows: 0 = absence of inflammation, 1 = mild inflammation (some vessels injected), 2 = moderate inflammation (diffuse injection of vessels, but individual vessels are still discernable) 3 = severe inflammation (intense injection of vessels, individual vessels not easily discernable).

  4. Total Ocular Symptoms Score (TOSS) [ Time Frame: After 3, 7 and 14 days of treatment ]
    The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. Each symptom is given a score: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  5. Ocular pain/discomfort: 4-point scale [ Time Frame: After 3, 7 and 14 days of treatment ]
    Overall ocular pain and discomfort will be evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).

  6. Use of rescue therapy [ Time Frame: After 3, 7 and 14 days of treatment ]
    All rescue therapy used following cataract surgery is to be reported at all visits.


Other Outcome Measures:
  1. Intraocular pressure (IOP) [ Time Frame: At the Screening Visit, day 4, day 8 and day 15 ]
    IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg.

  2. Visual acuity [ Time Frame: Measured on Day 15 ]
    Decrease in visual acuity assessed as per local clinical practice

  3. Adverse events [ Time Frame: From screening to Day 15 ]
    Adverse events will be described according to System Organ Classes (SOC) and Preferred Terms (PT) using the Medical Dictionary for Regulatory Activities (MedDRA) and will be presented by treatment group.

  4. Global evaluation [ Time Frame: At day 4, day 8 and day 15 ]
    Global evaluation will be evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability.

  5. Burning, stinging, blurred vision [ Time Frame: At day 4, day 8 and day 15 ]
    Burning, stinging, blurred vision will be evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  6. Assessment of patient diary (compliance) [ Time Frame: At day 4, day 8 and day 15 ]
    Compliance will be evaluated on Day 4, Day 8 and Day 15 by means of a patient diary in which the instillations are to be recorded.



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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 prior to surgery:

  1. Signed written informed consent
  2. Male or female, age ≥40 years
  3. Scheduled senile or presenile cataract surgery
  4. Willing to interrupt the use of contact lenses for the entire duration of the study
  5. Able and willing to follow study procedures
  6. Female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception

    Inclusion criteria following surgery:

  7. Surgery completed without complications

Exclusion Criteria:

  1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
  2. Patients undergoing bilateral cataract surgery
  3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
  4. Systemic diseases that may interfere with the results of the study
  5. Any condition that could interfere with correct instillation of eye drops
  6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
  7. Monocular patients
  8. Visual Acuity < 20/80 of the contralateral eye measured as ETDRS or Snellen
  9. Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
  10. Hypersensitivity to the study product or its excipients
  11. Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
  12. Pregnancy or breastfeeding

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): NCT03739528


Contacts
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Contact: Alessandro Colombo, Dr. +39 02 4385 0490 alessandro.colombo@ntcpharma.com
Contact: Francesco Bandello, Prof. +39 02 26436212 bandello.francesco@hsr.it

  Show 57 Study Locations
Sponsors and Collaborators
NTC srl
Investigators
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Principal Investigator: Francesco Bandello, Prof. Ospedale San Raffaele IRCCS S.r.l.
  Study Documents (Full-Text)

Documents provided by NTC srl:

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Responsible Party: NTC srl
ClinicalTrials.gov Identifier: NCT03739528     History of Changes
Other Study ID Numbers: LEVODESA_04-2017
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
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Cataract
Eye Diseases
Ophthalmic Solutions
Inflammation
Pathologic Processes
Lens Diseases
Dexamethasone
Dexamethasone acetate
Tobramycin, Dexamethasone Drug Combination
Levofloxacin
Ofloxacin
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents