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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10030045 |
E.1.2 | Term | Ocular infections, inflammations and associated manifestations |
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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% eyedrops are at least as effective as ketorolac 0.5% eyedrops in the prevention of ocular inflammation following cataract surgery. |
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E.2.2 | Secondary objectives of the trial |
Comparison of indomethacin 0.1% versus ketorolac 0.5% with regard to: •Aqueous flare, measured with an LFM, at Day 30 and Day 90 after cataract surgery. •Retinal thickness measured with an Optical Coherence Tomograph at Day 30 and Day 90. •Post surgical pain/discomfort immediately after surgery (Day 0) and 24 hours after surgery (Day 1)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
This study will include subjects who meet the following criteria: 1. 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 or general 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.
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E.4 | Principal exclusion criteria |
This study will exclude subjects who meet the following 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 diabetic retinopathy. 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 discontinueusage during the study 12. Subjects who have a history of asthma linked to acetylsalicylic acid or other non- steroidal 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: • Post menopausal • Surgically sterile • Using one of the following birth control methods throughout the duration of thestudy: • 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is aqueous flare, measured with an LFM, at Day 1 and Day 7 after cataract surgery.
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 |
investigator masked to the study treatment |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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
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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 | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |