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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543490
First Posted: March 5, 2012
Last Update Posted: December 15, 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
  Purpose
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: February 2018
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: April 2019 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


Contacts
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: December 15, 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
Blepharitis
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents