Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sun Pharmaceutical Industries Limited
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.
Age
17–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Are at least 17 years of age
Are scheduled for uncomplicated unilateral cataract surgery
Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
Are willing and able to follow all instructions and attend all study visits
Are willing to avoid disallowed medication for the duration of the study
If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
You may not be if
Have known sensitivity or poor tolerance to any component of the study drugs
Have any sign of iritis or scleritis in the study eye
Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
Have known blood dyscrasia or bone marrow suppression
Have any active corneal pathology in the study eye
Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
Have 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
Use of any medication the investigator feels may interfere with the study parameters
Clareo Health | 2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
