Phase 3
Completed N=808
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Source: ClinicalTrials.gov NCT03739528 ↗Enrolled (actual)
808
Serious AEs
0.8%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants Without Signs of Anterior Chamber Inflammation — 376; 373; 19; 20 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Signs of Anterior Chamber Inflammation |
376; 373; 19; 20 | — |
| SECONDARY Number of Participants With Endophthalmitis |
393; 393; 391; 393; 389; 391 | — |
| SECONDARY Number of Participants Without Signs of Anterior Ocular Chamber Inflammation |
395; 393; 0; 0; 289; 302 | — |
| SECONDARY Conjunctival Hyperemia |
337; 323; 58; 70; 348; 358 | — |
| SECONDARY Total Ocular Symptoms Score (TOSS) |
0.29; 0.37; 0.28; 0.26; 0.17; 0.17 | — |
| SECONDARY Ocular Pain/Discomfort: 4-point Scale |
360; 361; 35; 32; 366; 366 | — |
| SECONDARY Use of Rescue Therapy |
392; 392; 3; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03739528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.