Independent Comparative Study to Evaluate ISV-305 Compared to Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Inclusion Criteria:

- 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)

- Additional inclusion criteria also apply

Exclusion Criteria:

- 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

- Additional exclusion criteria also apply