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OpenTrials
Completed

NCT Number: NCT02752646

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Eye Associates, Laguna Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

nepafenac 0.3%

Drug

Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.

Other names: Ilevro

Ketorolac

Drug

Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.

Primary outcomes

  1. Tolerability of nepafenac vs ketorolac

    Time frame: 14-28 days

    Patients will fill out a survey describing eye drop tolerability at 14-28 days

Sponsors and collaborators

Lead sponsor

MDbackline, LLC

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2016
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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