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.
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.
Active immunosuppressive or autoimmune disease that, in the opinion of the Investigator, could affect ocular surface integrity.
Active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to impair wound healing.
Intraocular pressure (IOP) ≤6 mmHg in either eye at screening.
Clinically significant Fuchs' endothelial corneal dystrophy (Grade 4 or higher on clinical examination).
Parallel
Ophthalmic solution (matching formulation without ascorbic acid)
DrugVehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid)
Ascorbic acid ophthalmic solution 5%
DrugArm 2 - CA201A (ascorbic acid ophthalmic solution 5%)
Change in central corneal endothelial cell density associated with cataract surgery
Change from baseline in central corneal endothelial cell density (cells/mm²) in the study eye, measured by specular microscopy in the central corneal region
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Safety and tolerability will be evaluated in terms of treatment emergent AEs and serious adverse events. This includes the types, incidence, and severity of TEAEs.
Change From Baseline in Best-Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Safety and tolerability will be evaluated in terms of change from baseline in BCVA
Incidence of Corneal Oedema Assessed by Slit Lamp Biomicroscopy
The presence and incidence of corneal oedema in the study eye will be evaluated using slit lamp biomicroscopy.
Intraocular Pressure (IOP) Measurements
Intraocular pressure (mmHg) will be measured in the study eye using standard tonometry methods.
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