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 February 2016 by InSite Vision
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
First received: October 24, 2011
Last updated: February 25, 2016
Last verified: February 2016
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:

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: January 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (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


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

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
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, see Learn About Clinical Studies.

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

Contact: Judith Hutcheson jhutcheson@insite.com

Sponsors and Collaborators
InSite Vision
  More Information

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: February 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by InSite Vision:
Dry Eye

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

ClinicalTrials.gov processed this record on May 26, 2016