CClinicalTrials.gg
CompletedNCT00405730Updated Nov 18, 2016

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

A Phase 3 interventional study of Nepafenac 1mg/ml eye drops, suspension and Ketorolac Trometamol 5 mg/ml eye drops, solution in Cataracts, sponsored by Alcon Research. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
227
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation

02

Conditions studied

  • Cataracts

Browse trials for

Keywords

  • Cataracts
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 227 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Under 18.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
227 participants (actual)

Study arms

  • Experimental
    Nepafenac

    One drop in the study eye 3 times daily for 23 days

    Drug: Nepafenac 1mg/ml eye drops, suspension

  • Active comparator
    Ketorolac Trometamol

    One drop in the study eye 3 times daily for 23 days

    Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution

  • Placebo comparator
    Nepafenac Vehicle

    One drop in the study eye 3 times daily for 23 days

    Other: Nepafenac vehicle eye drops

Interventions

  • DrugNepafenac 1mg/ml eye drops, suspension

    One drop in the study eye 3 times daily for 23 days

  • DrugKetorolac Trometamol 5 mg/ml eye drops, solution

    One drop in the study eye 3 times daily for 23 days

  • OtherNepafenac vehicle eye drops

    One drop in the study eye 3 times daily for 23 days

06

What researchers measure

Primary outcomes

  1. Percentage of Patients with Day 14 Cure

    Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

    Time frame: Day 14

07

Study locations

1 site
  • Bordeaux
    Bordeaux, 33000, France
08

References and documents

Publications

  • Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33. PubMed 19668532 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00405730
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Nov 30, 2006
Start date
Nov 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Nov 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion