Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%

MDbackline

Status: Completed

Conditions: Cataract

Treatments: Drug: ketorolac; Drug: nepafenac 0.3%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02752646

ALC-15417759

Details and patient eligibility

About

This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

Full description

This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.

Enrollment: 200 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy.
2. Patients willing to take an electronic survey about their tolerability of either study medication.

Exclusion Criteria

1. Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.

2. Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:

   1. Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure.
   2. Clinically significant ocular trauma.
   3. Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
   4. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
   5. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)

3. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis

4. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)

5. Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)

6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)

7. Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey

8. Participation in this trial in the same patient's fellow eye.

9. Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

nepafenac 0.3%

Active Comparator group

Description:

Patients in this arm will receive nepafenac 0.3% eye drops once daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care.

Treatment:

Drug: nepafenac 0.3%

ketorolac 0.5%

Active Comparator group

Description:

Patients in this arm will receive ketorolac 0.5% eye drops four times daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care.

Treatment:

Drug: ketorolac