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Completed

NCT Number: NCT03739528

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona, Ancona, AN, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

prior to surgery:

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

Inclusion criteria

following surgery:

  • Surgery completed without complications

Exclusion criteria

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

Treatment and study plan

Levofloxacin + dexamethasone followed by dexamethasone

Drug

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 names: Levofloxacin + dexamethasone followed by Maxidex

Tobramycin + Dexamethasone

Drug

Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.

Other names: Tobradex

Primary outcomes

  1. Number of Participants Without Signs of Anterior Chamber Inflammation

    Time frame: Day 15

    The number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses has been tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS > - Δ. Where πT and πS are the number of participants without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.

Secondary outcomes

  1. Number of Participants With Endophthalmitis

    Time frame: Day 4, 8, 15

    The number of participants with endophthalmitis after administration of study treatment in the study was 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. Number of Participants Without Signs of Anterior Ocular Chamber Inflammation

    Time frame: Day 0 (screening), 4, 8

    Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).

  3. Conjunctival Hyperemia

    Time frame: Day 4, 8, 15

    Conjunctival hyperemia was 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: Day 4, 8, 15

    The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. A score was given in the presence of symptoms: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  5. Ocular Pain/Discomfort: 4-point Scale

    Time frame: Day 4, 8, 15

    Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).

  6. Use of Rescue Therapy

    Time frame: During all the treatment until day 15

    All rescue therapy used following cataract surgery is to be reported at all visits.

Other outcomes

  1. Intraocular Pressure (IOP)

    Time frame: At day 0 (screening) and at day 4, 8, 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: At day 0 (screening) and at day 15

    Visual acuity was assessed as per local clinical practice, i.e. with the Snellen (feet) or the ETDRS (meter) chart. Visual acuity was then analysed using decimal unit. Decimal score is the decimal expression of the Snellen (feet) or the ETDRS (meter) charts in which the numerator indicates the distance from the chart and the denominator indicates the size of the smallest line that can be read. Decimal values were provided directly from the investigator or computed as a result of the Snellen or ETDRS fraction.

    Generally decimal values from 0.01 to 0.10 indicate severe vision loss; decimal values from 0.125 to 0.25 indicate moderate vision loss; decimal values from 0.32 to 0.63 indicate mild vision loss; decimal values from 0.8 to 1.6 indicate normal vision.

    Lower decimal values correspond to a reduced visual acuity and worst outcomes, while higher decimal values indicate an improved visual acuity and better outcomes.

  3. Adverse Events

    Time frame: During all the treatment until day 15

    Adverse events were described according to System Organ Classes (SOC) and Preferred Terms (PT) using the Medical Dictionary for Regulatory Activities (MedDRA) and were presented by treatment group.

  4. Global Evaluation of Local Tolerability

    Time frame: Day 4, 8, 15

    Global evaluation was 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: Day 4, 8, 15

    Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

  6. Assessment of Patient Diary (Compliance)

    Time frame: Day 15

    Treatment compliance is derived from the number of instillations each day during the study treatment exposure

Sponsors and collaborators

Lead sponsor

NTC srl

Industry

Registry information

Official study 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

Acronym: LEADER7

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2018
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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