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

NCT ID: NCT02752646

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-03-01

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

nepafenac 0.3%

Intervention Type: DRUG

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

ketorolac 0.5%

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.

Group Type: ACTIVE_COMPARATOR

ketorolac

Intervention Type: DRUG

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

Interventions

nepafenac 0.3%

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

Intervention Type: DRUG

ketorolac

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

Intervention Type: DRUG

Other Intervention Names

Ilevro

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

MDbackline, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A Hovanesian, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA Jules Stein Eye Institute

Locations

Harvard Eye Associates

Laguna Hills, California, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16196117 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14508260 (View on PubMed)

Other Identifiers

ALC-15417759

Identifier Type: -

Identifier Source: org_study_id