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CataractQDNCT01847638

Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery

A study testing Prolensa (bromfenac 0.07%) and Ilevro (nepafenac 0.3%) in people with Cataract and Retinal Edema, run by Melissa Toyos at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract, Retinal Edema, Inflammation
What is being tested?
Prolensa (bromfenac 0.07%) and Ilevro (nepafenac 0.3%)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Apr 2013to 23 Aug 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.
  • Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study.
  • Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
  • Are able to self administer test article (or have a caregiver available to instill all doses of test article).

Who cannot join

  • Have known hypersensitivity to bromfenac, nepafenac, loteprednol or any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
  • Have a known hypersensitivity to salicylates (i.e., aspirin) or NSAIDs (nonsteroidal antiinflammatory drug).
  • Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
  • Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
  • Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.
  • Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
Show all 13Show fewer
  • Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye.
  • Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis.
  • Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
  • Have had radial keratotomy, corneal transplant, or corneal refractive surgery in the study eye within the last two years.
  • Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
  • Are pregnant or nursing/lactating.
  • Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Toyos Clinic

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD for Treatment of Ocular Inflammation Associated With Cataract Surgery

To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.

Read the detailed description

To investigate the clinical outcomes for inflammation, visual acuity and macular thickness after treatment with Prolensa (bromfenac ophthalmic solution) 0.07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Being tested
Prolensa (bromfenac 0.07%), Ilevro (nepafenac 0.3%)
Keywords
Retinal edema, Cataract, inflammation
Medical subject headings
Cataract, Papilledema, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolensa (bromfenac 0.07%)Drug

    Also called bromfenac ophthalmic solution 0.07%

    Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

  • Ilevro (nepafenac 0.3%)Drug

    Also called nepafenac ophthalmic suspension 0.3%

    Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Study groups in NCT01847638
Study groupRoleWhat they receive
Prolensa (bromfenac 0.07%)Active comparatorSubjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
Receives: Drug: Prolensa (bromfenac 0.07%)
Ilevro (nepafenac 0.3%)Active comparatorSubjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
Receives: Drug: Ilevro (nepafenac 0.3%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment of Inflammation Associated With Cataract Surgery

    Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=>

    Measured: change from baseline to final at post op 42 days +/-7 days

Secondary outcomes (1)

  1. Visual Acuity

    ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes.

    Measured: baseline score to final postoperative visit at 42 days +/-7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study start1 Apr 2013
  3. Primary completion16 Jul 2016
  4. Study completion23 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847638
Sponsor's protocol ID
MMT-2013
Acronym
QD
Status last verified
Oct 2018
First submitted
16 Apr 2013
Last updated
14 Nov 2018
Data monitoring committee
No

Publications

  • Toyos MM. Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification. Ophthalmol Ther. 2019 Jun;8(2):261-270. doi: 10.1007/s40123-019-0174-x. Epub 2019 Mar 13.

    PubMed 30868419

Questions about this trial

What is this clinical trial studying?

A study testing Prolensa (bromfenac 0.07%) and Ilevro (nepafenac 0.3%) in people with Cataract and Retinal Edema, run by Melissa Toyos at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment of Inflammation Associated With Cataract Surgery (time frame: change from baseline to final at post op 42 days +/-7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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