Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 1 - Any |
Updated: | 3/1/2019 |
Start Date: | March 30, 2018 |
End Date: | December 2019 |
Contact: | Charlotte Baenziger |
Email: | charlotte.baenziger@sunpharma.com |
Phone: | 510-605-6007 |
A Phase 3, Multicenter, Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-305 (0.1% Dexamethasone) Compared to Vehicle in the Treatment of Subjects With Blepharitis
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.
(Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active,
symptomatic Blepharitis.
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
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