Treatment of Ocular Inflammation Associated With Cataract SurgeryPhase 4NCT03886779

Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

A Phase 4 study testing Bromfenac and Nepafenac in people with Treatment of Ocular Inflammation Associated With Cataract Surgery, run by Silverstein Eye Centers.

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

Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (nepafenac Ophthalmic Suspension) 0.3% QD with extra (pulse) dose on day of surgery for Treatment of Ocular Inflammation Associated with Cataract Surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Treatment of Ocular Inflammation Associated With Cataract Surgery
What is being tested?: Bromfenac and Nepafenac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: No sites listed yet
Study dates: 30 Oct 2013to Mar 2019
Phase: Phase 4
Are there results?: None posted in the registry

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
Adult, Older adult

Who may be able to join

Are male or female at least 18 years of age who are scheduled for unilateral cataract surgery VIA phacoemulsification with posterior chamber intraocular lens implantation and for whom no other ophthalmic surgical procedures (e.g., relaxing incisions, iridectomy, conjunctival excisions, etc) are to be conducted 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 willing/able to return for all required study visits.
Are willing/able to follow instructions from the study investigator and his/her staff.
Are able to self administer test article (or have a caregiver available to instill all doses of test article).

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If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
Have IOP ≥ 5 mmHg and ≤ 22 mmHg (in study eye) without anti glaucoma therapy at the pre operative screening visit (if >22 mmHg, adjust following pachymetry)

Who cannot join

Have known hypersensitivity to bromfenac or nepafenac or to 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 to other non steroidal anti inflammatory drugs (NSAIDs).
Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in the study eye at the 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 the study.
Have used any ocular prostaglandins within 30 days prior to initiation of dosing with the test article or throughout the duration of the study.

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Have active corneal pathology noted in the study eye at the 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 the study eye is a criterion for exclusion.
Have any extraocular/intraocular inflammation in the study eye noted at the 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.

About this study

Official title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Read the detailed description

Name of Finished Product:

Prolensa (Bromfenac Ophthalmic Solution) 0.07% Bausch and Lomb, Rochester, NJ Dose: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one days prior to surgery (Day 1), continue on the day of surgery plus 1 hour before surgery and for 14 days after surgery.

Ilevro® (nepafenac ophthalmic suspension ) 0.3% This is a single-center, randomized, investigator and subject-masked, parallel group, and active-comparator controlled study.

Subjects will be screened for this study between 1 and 21 days prior to the initiation of dosing with the test article. Subjects who sign the informed consent form and meet all inclusion/exclusion criteria will be randomized to receive either Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD or Ilevro (nepafenac Ophthalmic Suspension) 0.3% (1:1) for 14 days after cataract extraction.

Conditions: Treatment of Ocular Inflammation Associated With Cataract Surgery
Being tested: Bromfenac, Nepafenac
Keywords: Post-Ocular Inflammation, Cataract Surgery

What participants receive

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

BromfenacDrug
0.7 MG/ML [Prolensa]
NepafenacDrug
3 MG/ML [Ilevro]

Study groups in NCT03886779
Study group	Role	What they receive
Prolensa (Bromfenac Ophthalmic Solution) 0.07%	Active comparator	Bausch and Lomb, Rochester, NJ Dose: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one days prior to surgery (Day 1), continue on the day of surgery plus 1 hour before surgery and for 14 days after surgery. Receives: Drug: Bromfenac
Ilevro® (nepafenac ophthalmic suspension ) 0.3%	Active comparator	Alcon Laboratories, Inc., Fort Worth, TX Dose: Subjects will instill one drop of test article into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one day prior to surgery (Day 1), continue on the day of surgery plus1 hour before surgery and for 14 days after surgery. Receives: Drug: Nepafenac

What is being measured

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

Outcome Change measured by Summed Ocular Inflammation Score (SOIS)
50 Subjects are planned, 25 per treatment group who are undergoing planned cataract extraction with posterior chamber intraocular lens implantation to evaluate the non-inferiority of Prolensa and Ilevro when administering a pulse dose in each arm 1 hour prior to surgery. Outcome measure is defined as SIOS score of zero (no cell or flare) on day 15 (day one being the day prior to surgery, and for 14 days following surgery
Measured: Day 1 through Day 15

Secondary outcomes (4)

Adverse Events
Adverse Events reported, elicited, and observed
Measured: 42 Days
Slit Lamp Biomicroscopy
Slit Lamp Biomicroscopy evaluated and observed within normal limits
Measured: 42 Days
Intraocular Pressure
Intraocular Pressure evaluated and observed within normal limits
Measured: 42 Days
Funduscopic Examination (Dilated)
Funduscopic Examination (Dilated) evaluated and observed within normal limits
Measured: 42 Days

Timeline

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

30 Oct 2013Mar 2019

First posted22 Mar 2019
Study start30 Oct 2013
Primary completion15 Feb 2017
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Treatment of Ocular Inflammation Associated With Cataract SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a single center, randomized, investigator masked, parallel group, and active-comparator controlled study to evaluate the clinical outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% for the treatment of ocular inflammation associated with cataract surgery
Masking: Single blind
Who is masked: Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03886779
Sponsor's protocol ID: BLMAIIT-02-13
Status last verified: Mar 2019
First submitted: 18 Mar 2019
Last updated: 1 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available

Publications

Silverstein SM. Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose. Ophthalmol Ther. 2019 Dec;8(4):577-587. doi: 10.1007/s40123-019-00215-y. Epub 2019 Sep 24.
PubMed 31552543

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial
ClinicalTrials.gov ID: NCT03886779
Acronym / sponsor ID: BLMAIIT-02-13
Conditions: Treatment of Ocular Inflammation Associated With Cataract Surgery
Keywords: Post-Ocular Inflammation, Cataract Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Silverstein Eye CentersUniversity, hospital or other
Collaborators: Bausch & Lomb Incorporated, Churchhill Communications, Statistics & Data Corporation
Study start: 30 Oct 2013 (actual)
Primary completion: 15 Feb 2017 (actual)
Study completion: Mar 2019 (actual)
First posted: 22 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Name of Finished Product:

Ilevro® (nepafenac ophthalmic suspension ) 0.3% This is a single-center, randomized, investigator and subject-masked, parallel group, and active-comparator controlled study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: This is a single center, randomized, investigator masked, parallel group, and active-comparator controlled study to evaluate the clinical outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% for the treatment of ocular inflammation associated with cataract surgery

Arm	Type	Receives
Prolensa (Bromfenac Ophthalmic Solution) 0.07%	Active comparator	Drug: BromfenacBausch and Lomb, Rochester, NJ Dose: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one days prior to surgery (Day 1), continue on the day of surgery plus 1 hour before surgery and for 14 days after surgery.
Ilevro® (nepafenac ophthalmic suspension ) 0.3%	Active comparator	Drug: NepafenacAlcon Laboratories, Inc., Fort Worth, TX Dose: Subjects will instill one drop of test article into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one day prior to surgery (Day 1), continue on the day of surgery plus1 hour before surgery and for 14 days after surgery.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Are male or female at least 18 years of age who are scheduled for unilateral cataract surgery VIA phacoemulsification with posterior chamber intraocular lens implantation and for whom no other ophthalmic surgical procedures (e.g., relaxing incisions, iridectomy, conjunctival excisions, etc) are to be conducted 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 willing/able to return for all required study visits.
Are willing/able to follow instructions from the study investigator and his/her staff.

Key exclusion criteria (13 listed)

Have known hypersensitivity to bromfenac or nepafenac or to 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 to other non steroidal anti inflammatory drugs (NSAIDs).
Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in the study eye at the 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 the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bromfenac0.7 MG/ML [Prolensa]	Drug	Prolensa (Bromfenac Ophthalmic Solution) 0.07%
Nepafenac3 MG/ML [Ilevro]	Drug	Ilevro® (nepafenac ophthalmic suspension ) 0.3%

Primary outcome

Outcome Change measured by Summed Ocular Inflammation Score (SOIS)
Time frame: Day 1 through Day 15
50 Subjects are planned, 25 per treatment group who are undergoing planned cataract extraction with posterior chamber intraocular lens implantation to evaluate the non-inferiority of Prolensa and Ilevro when administering a pulse dose in each arm 1 hour prior to surgery. Outcome measure is defined as SIOS score of zero (no cell or flare) on day 15 (day one being the day prior to surgery, and for 14 days following surgery

4 secondary outcomes

Adverse Events
Time frame: 42 Days
Slit Lamp Biomicroscopy
Time frame: 42 Days
Intraocular Pressure
Time frame: 42 Days
Funduscopic Examination (Dilated)
Time frame: 42 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
Derived from this study: PubMed 31552543Silverstein SM. Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose. Ophthalmol Ther. 2019 Dec;8(4):577-587. doi: 10.1007/s40123-019-00215-y. Epub 2019 Sep 24.
Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven M Silverstein, MD principal investigator

Silverstein Eye Centers

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bromfenac and Nepafenac in people with Treatment of Ocular Inflammation Associated With Cataract Surgery, run by Silverstein Eye Centers.

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 9 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Outcome Change measured by Summed Ocular Inflammation Score (SOIS) (time frame: Day 1 through Day 15). 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 NCT03886779, 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 1 Apr 2019.