Phase 3 N=260 Randomized Quadruple-blind Treatment

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

Inflammation and Pain Associated With Cataract Surgery

Bottom Line

View on ClinicalTrials.gov: NCT03192137 ↗

Enrolled (actual)

260

Serious AEs

1.3%

Results posted

Jun 2020

Primary outcome: Primary: 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 — 69; 16; 0; 0 participants — p=0.0005

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ISV-305 (Drug); Vehicle (Other)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: Sun Pharmaceutical Industries Limited
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	69; 16; 0; 0; 64; 30	0.0005 sig
SECONDARY Proportion of Participants Who Achieved a Pain Score of 0 on the Visual Analog Scale (VAS) for Each Post-surgical Assessment	103; 29; 133; 44; 137; 49	<0.0001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03192137). 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.