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(352) 733-0111

KOWA 301

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.

Details

Full study title A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12 Week Administration With Two Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy
Protocol number OCR42270
ClinicalTrials.gov ID NCT05795699
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Is at least 18 years old at the screening visit (Visit 1)

  • Has a diagnosis of FECD at Visit 1

  • Meets all other inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

  • Is a female patient of childbearing potential and any of the following is true:

    1. is pregnant or lactating/breastfeeding, or

    2. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)

  • Has a study eye with a history of cataract surgery within 90 days of Visit 1

  • Meet any other exclusion criteria outlined in clinical study protocol

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Sonal Tuli
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.