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Eye drops aim to speed corneal healing after cataract surgery

NCT ID NCT05528172

Disease control Sponsor: Kowa Research Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether ripasudil (K-321) eye drops can improve corneal healing after cataract surgery. About 330 adults who have had cataract surgery will receive either the active eye drops or a placebo for 12 weeks, with a follow-up extension. The main goal is to see if the treatment helps maintain or restore the density of corneal endothelial cells, which are vital for keeping the cornea clear and preventing swelling.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ripasudil (K-321) eye drops
What this could lead to
If effective, ripasudil eye drops could become a standard treatment to speed corneal healing after cataract surgery, reducing the risk of lasting swelling and vision problems.
What could go wrong
This is a phase 3 trial, but results are not yet known. The eye drops may not prove more effective than placebo, and there could be side effects like eye irritation or redness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

330 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. is pregnant or lactating/breastfeeding, or 2. 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). 3. 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corneal edema after cataract surgery

Contacts and locations

Locations

  • Alvarado Eye Associates

    La Mesa, California, 91942, United States

  • Center for Sight

    Las Vegas, Nevada, 89145, United States

  • Centro Oftalmologico Metropolitano

    San Juan, 00921, Puerto Rico

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242, United States

  • Cincinnati Eye Institute

    Mason, Ohio, 45040, United States

  • Clayton Eye Clinical Research, LLC

    Morrow, Georgia, 30260, United States

  • Comprehensive Eye Care, Ltd.

    Washington, Missouri, 63090, United States

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona, 85032, United States

  • DCT-Shah Research, LLC dba Discovery Clinical Trials

    Mission, Texas, 78572, United States

  • Durrie Vision

    Overland Park, Kansas, 66210, United States

  • Eye Associates of Fort Myers

    Fort Myers, Florida, 33901, United States

  • Eye Care Institute/Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704, United States

  • Fraser Eye Care Center

    Fraser, Michigan, 48026, United States

  • Hill Country Eye Center

    Cedar Park, Texas, 78613, United States

  • Houston Eye Associates

    Houston, Texas, 77008, United States

  • Icon Eye Care

    Grand Junction, Colorado, 81501, United States

  • Inland Eye Specialists

    Hemet, California, 92545, United States

  • International Research Center

    Tampa, Florida, 33603, United States

  • Keystone Research

    Austin, Texas, 78751, United States

  • Lake Travis Eye & Laser Center

    Lakeway, Texas, 78738, United States

  • Levenson Eye Associates

    Jacksonville, Florida, 32204, United States

  • Louis M. Alpern, M.D., M.P.H.,P.A.

    El Paso, Texas, 79902, United States

  • Maine Eye Center

    Portland, Maine, 04101, United States

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670, United States

  • NYU Grossman School of Medicine

    New York, New York, 10017, United States

  • North Bay Eye Associates

    Petaluma, California, 94954, United States

  • Ophthalmology Associates

    St Louis, Missouri, 63131, United States

  • Ophthalmology Consultantants, Ltd.

    St Louis, Missouri, 63131, United States

  • Pendleton Eye Center

    Oceanside, California, 92056, United States

  • Premiere Practice Management, LLC

    Torrance, California, 90505, United States

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260, United States

  • Seeta Eye Center

    Poughkeepsie, New York, 12603, United States

  • Silverstein Eye Centers

    Kansas City, Missouri, 64133, United States

  • SoCal Eye Physicians and Associates

    Long Beach, California, 90805, United States

  • Tekwani Vision Center

    St Louis, Missouri, 63128, United States

  • Terry Eye Associates

    San Antonio, Texas, 78212, United States

  • United Medical Research Institute

    Inglewood, California, 90301, United States

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

  • Vance Thompson Vision ND

    West Fargo, North Dakota, 58078, United States

  • Vance Thompson Vision- NE

    Omaha, Nebraska, 68137, United States

  • Vance Thompson Vision-MT

    Bozeman, Montana, 59718, United States

  • Visionary Research Institute

    Newport Beach, California, 92663, United States

  • Wellish Vision Institute

    Las Vegas, Nevada, 89119, United States

  • Wolstan and Goldberg Eye Associates

    Torrance, California, 90505, United States