Phase 2
Completed N=60
Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
Source: ClinicalTrials.gov NCT01387464 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Mean Aqueous Humor Bromfenac Concentration — 49.3; 23.7 ng/mL
Summary
The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to routine cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Aqueous Humor Bromfenac Concentration |
49.3; 23.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
- If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
- Signature of the subject on the Informed Consent Form
- Willing and able to follow all instructions and attend all study visits
- Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Exclusion Criteria
- Use of any drug containing bromfenac within 2 weeks prior to surgery
- Contact lens wear during the dosing period
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
- Any serious complications with or macroscopic damage to the corneal epithelium
- Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
- Currently suffer from alcohol and/or drug abuse
- Prior participation in this study protocol
- Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
- A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Data sourced from ClinicalTrials.gov (NCT01387464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.