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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.
Verified July 2012 by InSite Vision
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01478555
First received: October 24, 2011
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye Disease
 Drug: ISV 101
 Phase 2

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: Basic Science
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by InSite Vision:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 of Bromfenac in DuraSite Drug: ISV 101
Bromfenac in DuraSite
Experimental: Dose 2 of Bromfenac in DuraSite Drug: ISV 101
Bromfenac in DuraSite
Experimental: Dose 3 of Bromfenac in DuraSite Drug: ISV 101
Bromfenac in DuraSite
Active Comparator: DuraSite Drug: ISV 101
Bromfenac in DuraSite
Active Comparator: Vehicle Drug: ISV 101
Bromfenac in DuraSite

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478555

Contacts
Contact: Elizabeth Padilla EPadilla@insite.com

Sponsors and Collaborators
InSite Vision
  More Information

No publications provided

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01478555     History of Changes
Other Study ID Numbers: C-10-101-001
Study First Received: October 24, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by InSite Vision:
Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013