Clinical trial NCT03192137: Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
Official title: A Phase 3, Randomized, Multicenter, Double-masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (0.1% Dexamethasone in DuraSite® 2) to DuraSite 2 Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation and Pain Associated With Cataract Surgery
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 260
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants With Anterior Chamber Cell (ACC) Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population
timeFrame: Day 15
Secondary outcomes:
measure: Proportion of Participants Who Achieved a Pain Score of 0 on the Visual Analog Scale (VAS) for Each Post-surgical Assessment
timeFrame: Day 1 to Day 29
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Clinical Research Center
state: Tennessee
Study officials:
References: