Comparative Study to Evaluate ISV-305 Compared to Vehicle in Non-Bacterial Blepharitis Subjects
This study is not yet open for participant recruitment.
Verified July 2012 by InSite Vision
Sponsor:
InSite Vision
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01543490
First received: February 28, 2012
Last updated: July 19, 2012
Last verified: July 2012
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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 |
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 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543490
Contacts
| Contact: Elizabeth Padilla | EPadilla@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: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blepharitis Eyelid Diseases Eye Diseases Dexamethasone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013