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

ISRCTN ISRCTN03110798
DOI https://doi.org/10.1186/ISRCTN03110798
Protocol serial number # 539
Sponsor Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)
Funder Bausch & Lomb GmbH (Germany)
Submission date
03/03/2010
Registration date
25/03/2010
Last edited
31/03/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michel Weber
Scientific

Service d’Ophthalmologie
Hotel Dieu CHU de Nantes
1 place Alexis Ricordeau
Nantes
44093
France

Study information

Primary study designInterventional
Study designMulticentre investigator blinded randomised active controlled parallel group trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA Multicentre, Investigator-Masked, Parallel–Group, Randomized, Study of the Efficacy and Safety of Indomethacin 0.1% Eyedrops Compared with Ketorolac 0.5% Eyedrops in Ocular Inflammation After Cataract Surgery
Study acronymIndocollyr Study
Study objectivesA treatment with indomethacin 0.1% is non-inferior to a treatment with ketorolac 0.5% in the prevention of ocular inflammation following cataract surgery.
Ethics approval(s)1. France (Lead Centre): Local Ethics Committee (Comité de Protection des Personnes [CPP] Tours, Ouest-1) approved on the 8th of February 2008 (ref: 2007-004686-18)
2. Poland: Local Ethics Committee (Komisja Bioetyczna, Akademia Medyczna) approved on the 31st of March 2008 (ref: KE-0254/58/2008)
3. Portugal: Local Ethics Committee (Comissao de Etica para a Investigacao Clínica [CEIC], Parque da Saúda de Lisboa) approved on the 14th of April 2008 (ref: CEIC 07128BU598)
4. Germany: Local Ethics Committee (Ärztekammer des Saarlandes, Ethikkommission) approved on the 25th of September 2008 (ref: Sn 148/08)
Potential subjects who meet eligibility requirements will be scheduled for 6 study visits over a period of approximately 90 days. Subjects who meet eligibility requirements will be randomized (1:1) to receive test (indomethacin 0.1%) or active-control (ketorolac 0.5%) in the study eye. Study eyes will receive 1 drop of study drug, four times daily, for 3 weeks.
Health condition(s) or problem(s) studiedCataract; surgery; phacoemulsification
InterventionPotential 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%) or active-control (ketorolac 0.5%) in the study eye. Study eyes will receive 1 drop of study drug, four times daily, for 3 weeks.

The test article is commercially available with different brand names in the countries where the study takes place. It is manufactured by Bausch & Lomb, Chauvin, Montpellier, France and contains indomethacin ophthalmic solution 0.1%, preserved with thiomersal (10 mg/100 ml).
The active control is commercially available Acular, marketed by Allergan Incorporated in France. Acular contains ketorolac tromethamine 0.5% and is preserved with benzalkonium chloride 0.01%.
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date17/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration120
Key inclusion criteriaSubjects 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
Key exclusion criteria1. 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)
Date of first enrolment08/04/2008
Date of final enrolment17/09/2009

Locations

Countries of recruitment

  • France
  • Germany
  • Poland
  • Portugal

Study participating centre

Service d’Ophthalmologie
Nantes
44093
France

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
BMC - Part of Springer Nature Springer Nature