Phase 3
Completed N=268
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Ocular Inflammation
Source: ClinicalTrials.gov NCT01808547 ↗
Enrolled (actual)
268
Serious AEs
0.8%
Results posted
Jul 2016
Primary outcomePrimary: Ocular Inflammation — 64; 19 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Inflammation |
64; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
- If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. 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 to avoid disallowed medications for the duration of the study
- Willing and able to follow all instructions and attend all study visits
- Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
- Additional inclusion criteria also apply
Exclusion Criteria
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
- Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- Currently suffer from alcohol and/or drug abuse
- 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
- Additional inclusion criteria also apply
Data sourced from ClinicalTrials.gov (NCT01808547). 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.