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

NCT02752646 | Completed

• 1 other identifier: ALC-15417759
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract

Keywords

cataract

Outcome Measures

Primary Outcomes (1)

• Tolerability of nepafenac vs ketorolac

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

  14-28 days

Study Arms (2)

nepafenac 0.3%

ACTIVE COMPARATOR

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.

Drug: nepafenac 0.3%

ketorolac 0.5%

ACTIVE COMPARATOR

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.

Drug: ketorolac

Interventions

nepafenac 0.3% DRUG

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

Also known as: Ilevro

nepafenac 0.3%

ketorolac DRUG

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

ketorolac 0.5%

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MDbackline, LLC: lead
• Alcon Research: collaborator

Study Sites (2)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Related Publications (2)

• Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

  PMID: 16196117 RESULT

• Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.

  PMID: 14508260 RESULT

MeSH Terms

Conditions

Cataract

Interventions

nepafenac; Ketorolac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John A Hovanesian, MD

  UCLA Jules Stein Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)