Cataract
Conditions
Interventions
Potential subjects who meet eligibility requirements will be scheduled for 6 study visits over a period of approximately 90 days. Subjects will be randomized (1:1) to receive test (indomethacin 0.1%)
Sponsors
Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must be of legal age (at least 18) and have full legal capacity to volunteer. 2. Subjects must read, understand, and sign the Institutional Review Board/Independent Ethics Committee approved Informed Consent Form. 3. Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical anaesthesia. 4. Subjects must have a preoperative flare = 15 ph/ms, measured with a laser flare meter (LFM) without pharmacological pupil dilation, within the 2 months preoperatively. 5. Subjects who are women of childbearing potential must have a negative urine pregnancy test at baseline. 6. Subjects who are able and willing to comply with all treatment and follow-up procedures
Exclusion criteria
Exclusion criteria: 1. Subjects who have an inflammatory and/or infectious pathology of the eye and its adnexa 2. Subjects who have a history of postoperative intraocular infection in the fellow eye 3. Subjects who have glaucoma in the study eye 4. Subjects who have post-traumatic cataract in the study eye 5. Subjects who have exfoliative syndrome 6. Subjects who have diabetes 7. Subjects who have an active peptic ulcer 8. Subjects who have severe hepatocellular impairment or severe renal impairment 9. Subjects who have a history of uveitis 10. Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents 11. Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study 12. Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration 13. Subjects with immunodepression 14. Subjects with a history of intolerance to the study drug or to any NSAI drug 15. Subjects who are monocular for any reason other than cataract 16. Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion 17. In the case of cataract surgery on the 2nd eye, if the subject was already included in the study for the 1st eye, the 2nd eye cannot be considered another study eye. 18. 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 cataract surgery is planned to occur for the fellow eye before Visit 5 (Day 30, ±3 days) is completed, the subject must be excluded. 19. Women who are pregnant or breastfeeding 20. Women who are sexually active and who do not fall into one of the following categories: 20.1. Post menopausal 20.2. Surgically sterile 20.3. Using one of the following birth control methods throughout the duration of the study: 20.3.1. Intrauterine device (>14 days) 20.3.2. Barrier method (condom or diaphragm) with spermicide (>14 days) 20.3.3. Hormonal contraception (same dose and same formulation for at least six months) Secondary criteria for exclusion from the efficacy analysis include perioperative complications (i.e., vitreous loss, complicated capsular rupture, and anterior chamber intraocular lens) which will also be considered adverse events (AEs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is aqueous flare, measured with an LFM, at Day 1 and Day 7 after cataract surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Aqueous flare, measured with an LFM, at Day 30 and Day 90 after cataract surgery 2. Change from baseline in retinal thickness measured with an Optical Coherence Tomograph at Day 30 and Day 90 3. Anterior chamber flare and cells, as well as conjunctival hyperaemia and perikeratic circle, measured through slit lamp examinations Post surgical pain/discomfort immediately after surgery (Day 0) and 24 hours after surgery (Day 1) 4. Change from baseline in the appearance of the macula and the rest of the retina, assessed through dilated, indirect funduscopy at Day 30 and Day 90 5. Use of concomitant medications to treat inflammation related to cataract surgery at each visit The safety endpoints include the following: 6. Corneal epithelial erosions at Day 7 and Day 30 measured with fluorescein strips and a cobalt filter on a slit lamp 7. Subjective tolerance to study drug upon instillation at Day 0 (prior to surgery), Day 7, and retrospective evaluation at Day 30 8. Best-corrected distance visual acuity (BCDVA) at Day 7, Day 30, and Day 90 9. Change from baseline in IOP at Day 7, Day 30, and Day 90 10. Adverse Events | — |
Countries
France, Germany, Poland, Portugal
Outcome results
None listed