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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: nepafenac 0.3%; Drug: ketorolac

• Registration Number: NCT02752646
• Lead Sponsor: MDbackline, LLC

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-27
• Status Verified: 2017-03
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nepafenac 0.3%	nepafenac 0.3%	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.
ketorolac 0.5%	ketorolac	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.

Primary Outcome Measures

Name	Time	Method
Tolerability of nepafenac vs ketorolac	14-28 days	Patients will fill out a survey describing eye drop tolerability at 14-28 days

Trial Locations

Locations (2)

Cincinnati Eye Institute; 🇺🇸 Edgewood, Kentucky, United States

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States