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

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00405730
Enrollment
227
Registered
2006-11-30
Start date
2005-11-30
Completion date
2006-07-31
Last updated
2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataracts

Keywords

Cataracts

Brief 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

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

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Under 18. * Other protocol-defined

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients with Day 14 CureDay 14Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026