Trial record 12 of 20 for:
Recruiting, Not yet recruiting, Available Studies | "Eyelid Diseases"
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
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.
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Information provided by (Responsible Party):
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.
Active, Symptomatic Blepharitis
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
| Estimated Enrollment:
| Anticipated Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2019 (Final data collection date for primary outcome measure)
Dexamethasone in DuraSite® 2 twice daily for 2 weeks
Placebo Comparator: 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:
|Accepts Healthy Volunteers:
- 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
- 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
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
History of Changes
|Other Study ID Numbers:
||February 28, 2012
||March 5, 2012
|Last Update Posted:
||December 15, 2017
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal