A multicenter, Investigator-Masked, Parallel Group, Randomized, Study of the Efficacy and Safety of Indomethacin 0.1 % Eyedrops Compared with Ketorolac 0.5% Eyedrops in the Ocular Inflammation After Cataract Surgery.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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.

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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