A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease (ISV-101)

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:
NCT01478555
First received: October 24, 2011
Last updated: June 19, 2014
Last verified: June 2014

October 24, 2011
June 19, 2014
January 2015
July 2015   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
Clinical improvement [ Time Frame: end of dosing ] [ Designated as safety issue: Yes ]
Clinically significant improvement in the study eye
Complete list of historical versions of study NCT01478555 on ClinicalTrials.gov Archive Site
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A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease
A Dose-Finding Study To Compare The Safety, Tolerability, And Efficacy Of Differing Dosing Regimens Of ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution) To Vehicle And DuraSite Alone In Dry Eye Disease Volunteers

The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Dry Eye Disease
Drug: ISV 101
Bromfenac in DuraSite
  • Experimental: Dose 1 of Bromfenac in DuraSite
    Intervention: Drug: ISV 101
  • Experimental: Dose 2 of Bromfenac in DuraSite
    Intervention: Drug: ISV 101
  • Experimental: Dose 3 of Bromfenac in DuraSite
    Intervention: Drug: ISV 101
  • Active Comparator: DuraSite
    Intervention: Drug: ISV 101
  • Active Comparator: Vehicle
    Intervention: Drug: ISV 101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
January 2016
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
  2. Negative pregnancy test prior to the conduct of any protocol-specific procedure. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
  3. Signature of the subject on the Informed Consent Form
  4. Willing to avoid disallowed medication for the duration of the study.
  5. Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
  6. Able and willing to follow study instructions
  7. Additional inclusion criteria also apply

Exclusion Criteria:

  1. Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study).
  2. Use of contact lenses during the study.
  3. Use of any concomitant topical ocular medications except for artificial tears during the dosing period
  4. Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
  5. Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
  6. 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
  7. Known hypersensitivity to any component of the study drug or procedural medications
  8. Participation in any other clinical trial within 30 days prior to screening
  9. Known hypersensitivity to NSAIDS
  10. Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit
  11. Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK)
  12. Cataract surgery within the past year.
  13. Known contraindication to the study drugs or any of their components
Both
18 Years and older
No
Contact: Judith Hutcheson jhutcheson@insite.com
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NCT01478555
C-10-101-001
No
InSite Vision
InSite Vision
Not Provided
Not Provided
InSite Vision
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP