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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by InSite Vision
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01543490
First received: February 28, 2012
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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

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: December 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543490

Contacts
Contact: Judith Hutcheson jhutcheson@insite.com

Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01543490     History of Changes
Other Study ID Numbers: C-12-305-001
Study First Received: February 28, 2012
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blepharitis
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on October 21, 2014