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

NCT07694375 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • Corneal Endothelial Cell Loss
  • Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery

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%)

Sponsors & Collaborators

  • Caravel Oculus Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-28
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694375 on ClinicalTrials.gov