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KOWA 303

  • 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 simultaneous cataract surgery and 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 Simultaneous Cataract Surgery and Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy
Protocol number OCR44063
ClinicalTrials.gov ID NCT05826353
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

  • Meet all other inclusion criteria outlined in the Clinical Study Protocol.

Exclusion Criteria:

  • Is a female subject 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)

  • Meet any other exclusion criteria outlined in the Clinical Study Protocol.

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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