A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Catar… (NCT07694375) | Clinical Trial Compass
RecruitingPhase 2
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Australia200 participantsStarted 2026-07-28
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject must voluntarily sign and date a Human Research Ethics Committee (HREC) approved informed consent form (ICF) prior to the initiation of any screening or study-specific procedures.
* In the Investigator's opinion, the subject is willing and able to comply with study instructions and complete all scheduled study visits.
* Male or female aged ≥18 and ≤85 years.
* Scheduled to undergo cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens.
* Has the potential to improve best-corrected visual acuity (BCVA) in the study eye following surgery, as judged by the Investigator.
* Has a nuclear cataract exhibiting a nuclear opalescence of Grade 3, 4, or 5 in the study eye according to the Lens Opacities Classification System III (LOCS III) classification. This includes pure nuclear cataracts as well as mixed-type cataracts (ie, nuclear opalescence grade 3 to 5 with or without co-existing cortical and/or posterior subcapsular opacities).
* Has corneal endothelium in the study eye that can be adequately assessed using specular microscopy, with sufficient image quality for endothelial cell density analysis.
* Has a central corneal ECD ≥1000 cells/mm² in the study eye at the Screening visit, as measured by specular microscopy.
* Has a pinhole visual acuity of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (approximately equivalent to 6/60 Snellen) in the study eye at the Screening visit, measured…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in central corneal endothelial cell density associated with cataract surgery
Timeframe: Visit 1: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery