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Nonsteroidal Anti-inflammatory Drug

Nepafenac 0.3% Opthalmic Suspension for Pseudoaphakia

Phase 3
Waitlist Available
Research Sponsored by Actavis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.

Eligible Conditions
  • Pseudoaphakia
  • Cataract

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cure at Day 14

Side effects data

From 2018 Phase 3 trial • 448 Patients • NCT03499873
5%
Intraocular pressure increased
5%
Headache
3%
Blood glucose increased
2%
Posterior capsule opacification
2%
Anterior chamber inflammation
2%
Urinary tract infection
2%
Eye pain
1%
Diabetes mellitus
1%
Conjunctival hyperaemia
1%
Open angle glaucoma
1%
Foreign body sensation in eyes
1%
Corneal abrasion
1%
Iris injury
1%
Eyelid exfoliation
1%
Conjunctival cyst
1%
Hyphaema
1%
Vitreous detachment
1%
Vitreous floaters
1%
Eye pruritus
1%
Bronchitis
1%
Corneal oedema
1%
Macular oedema
1%
Ocular discomfort
1%
Chalazion
1%
Exposure to toxic agent
1%
Procedural pain
1%
Photophobia
1%
Conjunctivitis allergic
1%
Eye inflammation
1%
Fibrin deposition on lens postoperative
1%
Post procedural inflammation
1%
Dizziness
1%
Migraine
1%
Cough
1%
Anterior chamber disorder
1%
Anterior chamber fibrin
1%
Conjunctival haemorrhage
1%
Blepharitis
1%
Vomiting
1%
Oedema peripheral
1%
Sensation of foreign body
1%
Drug hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nepafenac 0.3% Opthalmic Suspension
Ilevro 0.3% Opthalmic Suspension
Placebo (Vehicle) Opthalmic Suspension

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Nepafenac 0.3% Opthalmic SuspensionExperimental Treatment1 Intervention
Test product manufactured by Indoco Remedies, Ltd for Actavis LLC.
Group II: Ilevro 0.3% Opthalmic SuspensionActive Control1 Intervention
Reference product manufactured by Alcon Laboratories Inc.
Group III: Placebo (vehicle) Opthalmic SuspensionPlacebo Group1 Intervention
Placebo (vehicle) manufactured by Indoco Remedies, Ltd for Actavis LLC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nepafenac
FDA approved

Find a Location

Who is running the clinical trial?

Actavis Inc.Lead Sponsor
98 Previous Clinical Trials
24,799 Total Patients Enrolled
~58 spots leftby Dec 2025
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