Comparing the Efficacy and Safety of Indomethacin 0.1% Eyedrops versus Ketorolac 0.5% Eyedrops in Ocular Inflammation After Cataract Surgery

Completed

• Conditions: Eye Diseases; phacoemulsification; surgery; Cataract

• Registration Number: ISRCTN03110798
• Lead Sponsor: Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is aqueous flare, measured with an LFM, at Day 1 and Day 7 after cataract surgery