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RECRUITING
NCT07694375
PHASE2

A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery

Sponsor: Caravel Oculus Pty Ltd

View on ClinicalTrials.gov

Summary

This study is designed to assess whether an investigational eye drop called CA201A can help protect the cornea (the outer covering of the eye) and reduce damage to corneal endothelial cells following cataract surgery, without causing significant side effects. Cataract surgery is one of the common surgical procedures, however, it can sometimes lead to a loss of corneal endothelial cells, which are essential for maintaining the corneal clarity and long-term eye health. About 200 adults in Australia who are scheduled to have cataract surgery will be enrolled in this study following eligibility check. All eligible participants will be randomly assigned (by chance) to receive either the CA201A eye drops or a similar eye drop without the active ingredient. Neither the participant nor the study doctor will know the treatment each participant is receiving until the study is completed. All enrolled participants will place 1 drop of CA201A four times daily, starting 7 days prior to the surgery, continue on the day of surgery, and then keep using them for 4 weeks following surgery. After treatment, participants will be followed for up to 12 weeks after surgery in order to monitor safety and assess how well the treatment works. All participants will undergo standard cataract surgery and receive usual care; the study eye drops will be given in addition to this routine treatment. Throughout the study, doctors will measure changes in corneal endothelial cell density and perform other eye examinations to evaluate the treatment effect.

Official title: A Multicentre, Randomised, Double-masked, Vehicle-controlled, Parallel-arm, Phase 2 Study of the Safety and Efficacy of CA201A for the Prevention of Corneal Endothelial Cell Loss in Subjects Undergoing Cataract Surgery

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-07-28

Completion Date

2027-02

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

Ophthalmic solution (matching formulation without ascorbic acid)

Vehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid)

DRUG

Ascorbic acid ophthalmic solution 5%

Arm 2 - CA201A (ascorbic acid ophthalmic solution 5%)

Locations (8)

Canberra Eye Surgeons

Deakin, Australian Capital Territory, Australia

Nexus Eye Care Norwest

Baulkham Hills, New South Wales, Australia

Nexus Eye Care Blacktown

Blacktown, New South Wales, Australia

Eastwood Eye Specialists

Eastwood, New South Wales, Australia

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, Australia

Adelaide Eye and Retina Centre

Adelaide, South Australia, Australia

Hobart Eye Surgeons

Hobart, Tasmania, Australia

Launceston Eye Doctors

Launceston, Tasmania, Australia