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

Completed · Not applicable

Conditions studied: Cataract

In brief

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

Key facts

Study ID

NCT02752646

Run by

MDbackline, LLC

People needed

200

Starts

2016-04-01

Expected to finish

2017-03-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
• Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure.
• Clinically significant ocular trauma.
• Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
• Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
• Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
• Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
• 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)
• Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
• Participation in this trial in the same patient's fellow eye.
• Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.

Where it is running

• Harvard Eye Associates — Laguna Hills, California, United States
• Cincinnati Eye Institute — Edgewood, Kentucky, United States

Full record on ClinicalTrials.gov

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