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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752646
• Other study ID #: ALC-15417759
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: March 3, 2017
• Start date: April 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: March 2017
• Source: MDbackline, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• nepafenac 0.3%
Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
• ketorolac
Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.

Locations

Country	Name	City	State
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
MDbackline, LLC	Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of nepafenac vs ketorolac	Patients will fill out a survey describing eye drop tolerability at 14-28 days	14-28 days