Recruitment

Recruitment Status
Completed

Inclusion Criteria

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).
...
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).
Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.

Exclusion Criteria

Are pregnant or nursing/lactating.
Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
...
Are pregnant or nursing/lactating.
Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
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 history of abuse of alcohol/drugs within six months prior to the screening visit.
Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
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 had radial keratotomy, corneal transplant, or corneal refractive surgery in the study eye within the last two years.
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 prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
Have a known hypersensitivity to salicylates (i.e., aspirin) or NSAIDs (nonsteroidal antiinflammatory drug).
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 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 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.

Summary

Conditions
  • Cataract
  • Inflammation
  • Retinal Edema
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

Inclusion Criteria

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).
...
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).
Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.

Exclusion Criteria

Are pregnant or nursing/lactating.
Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
...
Are pregnant or nursing/lactating.
Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
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 history of abuse of alcohol/drugs within six months prior to the screening visit.
Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
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 had radial keratotomy, corneal transplant, or corneal refractive surgery in the study eye within the last two years.
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 prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
Have a known hypersensitivity to salicylates (i.e., aspirin) or NSAIDs (nonsteroidal antiinflammatory drug).
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 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 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.

Locations

Nashville, Tennessee, 37203
Nashville, Tennessee, 37203

Tracking Information

NCT #
NCT01847638
Collaborators
Bausch & Lomb Incorporated
Investigators
  • Principal Investigator: Melissa Toyos, MD Toyos Clinic
  • Melissa Toyos, MD Toyos Clinic