Clinical trial NCT02752646: Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
Official title: Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
Lead sponsor: MDbackline, LLC
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2016-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Tolerability of nepafenac vs ketorolac
timeFrame: 14-28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
Study officials:
affiliation: UCLA Jules Stein Eye Institute
name: John A Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.