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

This study is not yet open for participant recruitment.
Verified June 2017 by InSite Vision
ClinicalTrials.gov Identifier:
First Posted: March 5, 2012
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
InSite Vision
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.

Condition Intervention Phase
Active, Symptomatic Blepharitis Drug: ISV-305 Other: Vehicle Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • Reduction of total clinical sign and symptom score [ Time Frame: Day 15 ]
    The primary efficacy endpoint for the comparison of ISV-305 and Vehicle is the reduction of Day 1 total clinical sign and symptom score by at least 2 units at Day 15 with no worsening of any sign or symptom

Other Outcome Measures:
  • Additional Efficacy Endpoints: Patient-reported outcome questionnaire (PRO) [ Time Frame: Days 1, 15, 29 ]
    Mean scores and mean score changes for each domain of the PRO

Estimated Enrollment: 550
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-305 Drug: ISV-305
Dexamethasone in DuraSite® 2 twice daily for 2 weeks
Placebo Comparator: Vehicle Other: Vehicle
Placebo twice daily for 2 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543490

Contact: Charlotte Baenziger 510-747-1219 charlotte.baenziger@sunpharma.com

Sponsors and Collaborators
InSite Vision
  More Information

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01543490     History of Changes
Other Study ID Numbers: C-12-305-001
First Submitted: February 28, 2012
First Posted: March 5, 2012
Last Update Posted: August 24, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents