Phase 3
N=558
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
Active, Symptomatic Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT01543490 ↗Enrolled (actual)
558
Serious AEs
0.7%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants in the ITT Population With a Reduction in the Day 1 (Baseline) Total Clinical Signs and Symptom Score by at Least 2 Units at Day 15 With No Worsening of Any Sign or Symptom — 276; 129; 77; 56 Participants — p=0.0354
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ISV-305 (Drug); Vehicle (Other)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries Limited
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in the ITT Population With a Reduction in the Day 1 (Baseline) Total Clinical Signs and Symptom Score by at Least 2 Units at Day 15 With No Worsening of Any Sign or Symptom |
276; 129; 77; 56 | 0.0354 sig |
| SECONDARY Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population |
127; 52; 241; 138 | 0.1036 |
Summary
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.
Eligibility Criteria
Inclusion Criteria
- Are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis
- 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 (this applies to parent or caregiver for subjects too young to self-apply investigational product)
- 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 had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye
- Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test
- Have prior (within 30 days prior to dosing) 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
- Additional exclusion criteria also apply
Data sourced from ClinicalTrials.gov (NCT01543490). 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.