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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.

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
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002647-35-HU
Enrollment
Unknown
Registered
2005-08-18
Start date
2005-10-06
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

ocular pain and inflammation associated with cataract extraction and intraocular lens implantation

Interventions

Product Name: Nepafenac 0.1% Eye Drops, Suspension Pharmaceutical Form: Eye drops, suspension INN or Proposed INN: nepafenac CAS Number: 78281-72-8 Current Sponsor code: AL-6515 Other descriptive name

Sponsors

Alcon Research, Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults (18 years of age or older) of any race, who have a cataract, and are expected to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber IOL. 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

Exclusion criteria: Use of topical ocular or systemic steroids within 14 days prior to surgery. Use of topical ocular, inhaled or systemic NSAIDs within 7 days of surgery (exception: low dose aspirin, up to 100mg, permitted). Any intraocular inflammation or more than mild ocular pain at the baseline visit Women of child-bearing potential who are breast-feeding, have a positive urine pregnancy test at baseline, or not using adequate birth control. History of chronic or recurrent inflammatory eye disease in the operative eye. Proliferative diabetic retinopathy or moderate to severe non-proliferative diabetic retinopathy in the operative eye; or uncontrolled diabetes mellitus. Known or suspected allergy or hypersensitivity to NSAIDs, or any component of the study medication.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety and efficacy of nepafenac 0.1% eye drops, suspension compared to placebo with ketorolac trometamol 0.5% eye drops, solution (Acular) as a reference standard for the prevention and treatment of ocular pain and ocular inflammation after cataract extraction by phacoemulsification with posterior chamber IOL implanation;Secondary Objective: ;Primary end point(s):—

Countries

Hungary, Italy, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026