Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Active, Symptomatic Blepharitis

Treatments: Other: Vehicle; Drug: ISV-305

Study type: Interventional

Funder types: Industry

Identifiers

NCT01543490

C-12-305-001

Details and patient eligibility

About

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.

Enrollment: 558 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 2 patient groups, including a placebo group

ISV-305

Experimental group

Description:

0.1% dexamethasone in DuraSite® 2

Treatment:

Drug: ISV-305

Vehicle

Placebo Comparator group

Description:

DuraSite® 2 vehicle

Treatment:

Other: Vehicle