E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of ocular inflammation in adults patients undergoing cataract surgery. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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). |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
single-masked (investigator) with patient masked to the study treatment name,comparative,multicentre |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |