Working... Menu
Trial record 65 of 8397 for:    Ophthalmopathy

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

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. Read our disclaimer for details. Identifier: NCT01478555
Recruitment Status : Withdrawn (Project postponed)
First Posted : November 23, 2011
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
InSite Vision

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Disease Drug: ISV 101 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in Corneal Fluorescein Staining [ Time Frame: Week 8 ]
  2. Improvement in OSDI Scoring [ Time Frame: Week 8 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Layout table for additonal information
Responsible Party: InSite Vision Identifier: NCT01478555     History of Changes
Other Study ID Numbers: C-10-101-001
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InSite Vision:
Dry Eye

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