Subjects scheduled to undergo cataract surgery MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders
Conditions
Interventions
Trade Name: LOTEMAX
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Loteprednol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 190-
Sponsors
BAUSCH&LOMB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects enrolled in this study must satisfy the following inclusion criteria: 1. Must be of legal age (at least 18) and have full legal capacity to volunteer, 2. Must read, understand, and sign the IEC approved Informed Consent Form (ICF), and provide authorization as appropriate for local privacy regulations, 3. Must be scheduled to undergo cataract surgery in one eye, involving phacoemulsification with posterior chamber IOL implantation using topical anesthesia, 4. Females who are sexually active must fall into one of the following categories: Post menopausal Surgically sterile Currently using one of the following birth control methods throughout the duration of the study: -Intrauterine device (>14 days) -Barrier method (condom or diaphragm) with spermicide (>14 days) -Hormonal contraception (same dose and same formulation for at least six months 5. Women of childbearing potential who have a negative urine pregnancy test, 6. Must be willing to wait to undergo cataract surgery on the fellow eye until after the Visit 5 (Day 14 ±1 day) assessments have been completed. 7. Must be able and willing to comply with all treatment and follow up procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects enrolled in this study must not meet any of the following exclusion criteria: 1. Participating in any investigational drug or device study within 30 days prior to entry into this study, 2. Inflammatory and/or infectious pathology of the eye and its adnexa, 3. History of postoperative intraocular infection in the fellow eye, 4. Glaucoma in study eye, 5. Post-traumatic cataract in study eye, 6. Exfoliative syndrome, 7. Diabetes, 8. History of uveitis, 9. With any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents, 10. Immunodepression, 11. A history of intolerance to the study drugs, to steroids or to NSAIDs, 12. Monocular (for any other reason than cataract), 13. Treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion in this study, 14. Currently taking glaucoma medications, cholinolytic drugs, cycloplegic or mydriatic agents (other than those required for the surgical procedure) 15. Currently taking oral anticoagulants, heparin, lithium, ticlopidine and high doses of methotrexate (≥ 15 mg/week), 16. Currently taking acetylsalicylic acid at doses > 300 mg/day, 17. Allergy to lidocaine, 18. Allergy to fluorescein, 19. Fellow eye previously enrolled in this study, 20. Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to demonstrate that LE ophthalmic suspension 0.5% is non-inferior to dexamethasone 0.1% in the treatment of ocular inflammation following uncomplicated cataract surgery when administered in combination with a preoperative and postoperative regimen of indomethacin 0.1%;Secondary Objective: The secondary efficacy endpoints include the following: Anterior chamber flare and cells at Day 7, Day 14 and Day 60 will be measured through the slit lamp/biomicroscopy examination. Retinal thickness will be measured with an OCT3 machine at the Screening Visit, Day 1, Day 14 and Day 60. The change from Day 1 central retinal thickness of the study eye and the mean change from Day 1 of 4 pericentral quadrants will be assessed. Conjunctival hyperaemia and perikeratic circle, will be measured through the slit lamp/biomicroscopy examinations at Day 1, Day 7, Day 14 and Day 60.;Primary end point(s): Efficacy The primary endpoint is the prevention/reduction of ocular inflammation, defined as an absence or reduction from Day 1 to Day 7 in both flare and cells, will be measured through the slit lamp/biomicroscopy examination. Safety Adverse Events: information regarding any subject- or Investigator-reported AEs will be obtained at each study visit.Retrospective subjective tolerance to study drug upon instillation will be assessed at Day 7 and Day 14. Tolerance will be rated by the subject on a scale from 1 to 4, where 1 = Very Good and 4 = Very Bad. BCVA will be obtained at the Day 7, Day 14, and Day 60 Visits. IOP will be measured at Day 7, Day 14, and Day 60. Fundoscopy will be performed at Day 14 and Day 60. | — |
Countries
Italy
Outcome results
None listed