Prevention of ocular inflammation in adults patients undergoing cataract surgery.
Conditions
Interventions
Trade Name: Indocollyre 0.1%, collyre en solution
Product Name: Indomethacin 0.1%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: indomethacin
CAS Number: 0000053-86-1
Concentration unit
Sponsors
Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients, age = 18 years • Planned to undergo cataract surgery on one eye by phaco-emulsification with posterior chamber intraocular lens and using topical anaesthesia. • Pre-operative flare = 15 ph/ms, measured with the laser flare meter (LFM) without pharmacological pupil dilation, within the 2 months preoperatively • Subject must read, understand and signed the Inform Consent Form. • Women of childbearing potential, must have negative urine pregnancy test at baseline. • Subject 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: • Inflammatory and/or infectious pathology of the eye and its adnexa • History of post-operative intraocular infection in the fellow eye • Glaucoma in the study eye • Post-traumatic cataract in the study eye • Exfoliative syndrome • Diabetes • History of uveitis • Any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents • Immunodepression • History of intolerance to the tested drugs and to any NSAI drug • Monocular patients (for any other reason than cataract) • Patients treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion • In the case of cataract surgery on the 2nd eye, if the subject was already included inthe study for the 1st eye, teh 2nd eye cannot be considered another study eye; • Pregnant and lactating women • Active peptic ulcer • Severe hepatocellular or renal impairment • Subject who take acetylsalicylic acid at doses >100mg and cannot discontinue usage during the study. • Asthma linked to acetylsalicylic acid or NSAI • Surgery planned during the study other than cataract surgery or cataract surgery on the fellow eye. • Subjects who have surgery planned to occur during the course of the study other than cataract surgery on the study eye or cataract surgery on the fellow eye. If surgery is planned to occur for the fellow eye before Visit 5 (Day 30 ± 3 days) is completed, the subject must be excluded. • Women sexually active and who do not fall into one of the following categories : Post menopausal / Surgically sterile / Using one birth control methods throughout the duration of the study (Intrauterine device > 14 days - Barrier method, diaphram or condom, with spermicide < 14 days- hormonal contraception, same dose and same formulation for at least 6 months) .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that indomethacin 0.1% eye drops are at least as effective as ketorolac 0.5% eye drops in the prevention of ocular inflammation (aqueous flare) following cataract surgery measured by laser Flare Meter 24 hours and 1 week after surgery.;Secondary Objective: Comparison of indomethacin 0.1% versus ketorolac 0.5% with regard to : * Aqueous flare 1 month and 3 months after surgery; *retinal thickness measured with OCT (Day 30 - Day 90) * Post chirurgical pain / discomfort;Primary end point(s): Efficacy Aqueous flare measured with a laser flare meter at Day 1 and Day 7 after cataract surgery (mean of at least 5 values measured in darkness, without pupil dilation, at each time of assessment). | — |
Countries
France, Germany, Portugal
Outcome results
None listed