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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

nepafenac 0.3%

ketorolac

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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)
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.

Sites / Locations

Harvard Eye Associates
Cincinnati Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

nepafenac 0.3%

ketorolac 0.5%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tolerability of nepafenac vs ketorolac

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02752646

First Posted

April 25, 2016

Last Updated

March 3, 2017

Sponsor

MDbackline, LLC

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT02752646

Brief Title

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

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

March 1, 2017 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MDbackline, LLC

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nepafenac 0.3%

Arm Type

Active Comparator

Arm Description

Arm Title

ketorolac 0.5%

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

nepafenac 0.3%

Other Intervention Name(s)

Ilevro

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ketorolac

Intervention Description

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

Primary Outcome Measure Information:

Title

Tolerability of nepafenac vs ketorolac

Description

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

Time Frame

14-28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John A Hovanesian, MD

Organizational Affiliation

UCLA Jules Stein Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harvard Eye Associates

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Cincinnati Eye Institute

City

Edgewood

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to make individual patient data available.

Citations:

PubMed Identifier

16196117

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.

Results Reference

result

PubMed Identifier

14508260

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.

Results Reference

result

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

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