Phase 3
N=246
2nd Study to Assess 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: NCT03192150 ↗Enrolled (actual)
246
Serious AEs
0.4%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Anterior Chamber Cell Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population — 92; 16; 0; 1 Participants — p=< 0.0001
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
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anterior Chamber Cell Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population |
92; 16; 0; 1; 41; 27 | < 0.0001 sig |
| SECONDARY Number of Participants Who Achieve a Pain Score of 0 on the Visual Analog Scale (VAS) (0-100 mm Scale) for Each Post-surgical Assessment at Days 1, 8, 15, 18, and 29 |
87; 29; 117; 39; 119; 41 | 0.0054 sig |
Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (Dexamethasone in DuraSite® 2) compared to 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
Data sourced from ClinicalTrials.gov (NCT03192150). 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.