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Completed

NCT Number: NCT05528172

A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery

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Key information

Conditions

Corneal Edema After Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Oftalmologico Metropolitano, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is at least 18 years old at the screening visit (Visit 1).
  • Is planning to undergo cataract surgery in the study eye and has had cataract surgery at Visit 2.
  • Can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed.
  • Meet all other inclusion criteria outlined in clinical study protocol.

Exclusion criteria

  • Is a female subject of childbearing potential and any of the following is true:
  • is pregnant or lactating/breastfeeding, or
  • has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy).
  • has a positive urine pregnancy test result at Visit 2 before cataract surgery.
  • Had intraocular surgery (non-laser surgery) in the study eye within 6 months of Visit 1.
  • Had intraocular laser surgery in the study eye within 3 months of Visit 1.
  • Meet any other exclusion criteria outlined in clinical study protocol

Treatment and study plan

Ripasudil

Drug

K-321 ophthalmic solution

Other names: K-321

Placebo

Drug

Placebo ophthalmic solution

Primary outcomes

  1. Change in Central Corneal Endothelial Cell Density (ECD) at Week 12

    Time frame: Baseline to Week 12

    Corneal ECD measurement captured by specular microscopy

Secondary outcomes

  1. Change in Central Corneal ECD

    Time frame: Baseline to Week 26

    Corneal ECD measurement captured by specular microscopy

  2. Change in Peripheral Corneal ECD

    Time frame: Baseline to Week 26

    Corneal ECD measurement captured by specular microscopy

  3. Change in Corneal Thickness

    Time frame: Baseline to Week 26

    measured in micrometers by contact ultrasound pachymetry, or optical pachymetry

  4. Change in corneal edema

    Time frame: Baseline to Week 26

    assessed as either being present or absent during slit-lamp examination

  5. Change in Best-Corrected Visual Acuity (BCVA)

    Time frame: Baseline to Week 26

    Measured by ETDRS scale

  6. Change in Vision-related quality of life

    Time frame: Baseline to Week 26

    Visual Functioning Questionnarie-25 (VFQ 25, Version 2000)

  7. Number of Participants with Adverse Events and Treatment Emergent Adverse Events

    Time frame: Baseline to Week 26

    Coded using the MedDRA dictionary (the most recent version, ver. 24.1 or later)

  8. Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy

    Time frame: Baseline to Week 26

    Graded as Normal or Abnormal

  9. Safety Assessment of Intraocular Pressure (IOP)

    Time frame: Baseline to Week 26

    Results will be recorded in mm Hg

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study title

A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Treatment and 14-week Extension, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.