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

This study is not yet open for participant recruitment.
Verified September 2013 by InSite Vision
Information provided by (Responsible Party):
InSite Vision Identifier:
First received: February 28, 2012
Last updated: September 17, 2013
Last verified: September 2013

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite®) compared to Vehicle in the treatment of subjects with Non-Bacterial Blepharitis.

Condition Intervention Phase
Non-Bacterial Blepharitis
Drug: ISV-305
Other: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-305 (Dexamethasone in DuraSite®) Compared to Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis

Resource links provided by NLM:

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • Clinical Resolution [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
    The primary efficacy endpoint for the comparison of ISV-305 and Vehicle is complete clinical resolution of signs and symptoms at Day 15.

Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-305 Drug: ISV-305
Dexamethasone in DuraSite® twice daily for 2 weeks
Placebo Comparator: Vehicle Other: Vehicle
Placebo twice daily for 2 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are at least 18 years of age.
  • Signature of the subject or legally authorized representative on the Informed Consent Form.
  • 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 and use effective contraception for the duration of the study.
  • 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 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 corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters within 14 days of enrollment.
  • 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.
  • Additional exclusion criteria also apply.
  Contacts and Locations
Please refer to this study by its identifier: NCT01543490

Contact: Judith Hutcheson

Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision Identifier: NCT01543490     History of Changes
Other Study ID Numbers: C-12-305-001
Study First Received: February 28, 2012
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on April 17, 2014