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.
This is a multicenter, randomized, double-masked, vehicle-controlled, parallel-arm, Phase 2 study designed to evaluate the safety and efficacy of CA201A, a 5% ascorbic acid ophthalmic solution, for the prevention of corneal endothelial cell loss in subjects undergoing cataract surgery. The study consists of three periods: * Screening Period: Up to 23 days before the Baseline \& treatment visit (Day -7) * Treatment Period: Subjects will self-administer the study intervention (CA201A or vehicle) topically to the study eye, one drop four times daily (QID), beginning on Day -7 and continuing through Day 28 post-surgery. On the day of surgery (Day 0), dosing should be administered prior to surgery according to the scheduled regimen. Postoperative dosing on Day 0 may be delayed or omitted if the operated eye is padded or covered immediately following surgery, in accordance with standard surgical practice. Study intervention should be resumed as soon as clinically appropriate. * Follow-up Period: Participants will be followed through Week 12 (day 84 ± 5 days) post-surgery for assessment of safety and efficacy endpoints. Eligible participants planning to undergo cataract extraction by phacoemulsification will be randomized in a 1:1 ratio to one of two treatment arms. Study treatment will begin 7 days prior to cataract surgery, continue on the day of surgery, and be maintained for 4 weeks postoperatively. All participants will undergo standard-of-care phacoemulsification cataract surgery. The study intervention is administered in addition to usual perioperative management. Surgical procedures will reflect routine clinical care, with protocol-specified documentation of key intra-operative parameters (e.g., cumulative dissipated energy, ultrasound time, irrigation volume, and intra-operative complications) to support interpretability of endothelial cell outcomes. The expected duration of participation for each participant is approximately 12 weeks post-surgery (up to approximately 16 weeks including screening).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Vehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid)
Arm 2 - CA201A (ascorbic acid ophthalmic solution 5%)
Canberra Eye Surgeons
Deakin, Australian Capital Territory, Australia
NOT_YET_RECRUITINGNexus Eye Care Norwest
Baulkham Hills, New South Wales, Australia
NOT_YET_RECRUITINGNexus Eye Care Blacktown
Blacktown, New South Wales, Australia
NOT_YET_RECRUITINGEastwood Eye Specialists
Eastwood, New South Wales, Australia
RECRUITINGSydney Retina Clinic & Day Surgery
Sydney, New South Wales, Australia
RECRUITINGAdelaide Eye and Retina Centre
Adelaide, South Australia, Australia
NOT_YET_RECRUITINGHobart Eye Surgeons
Hobart, Tasmania, Australia
NOT_YET_RECRUITINGLaunceston Eye Doctors
Launceston, Tasmania, Australia
NOT_YET_RECRUITINGChange 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
Time frame: Visit 1: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
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.
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
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
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
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.
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Intraocular Pressure (IOP) Measurements
Intraocular pressure (mmHg) will be measured in the study eye using standard tonometry methods.
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Corneal endothelial cell morphology
Changes from baseline in corneal endothelial cell morphology parameters (coefficient of variation in cell size and percentage of hexagonal cells) will be assessed in the study eye.
Time frame: Day -7 ± 2 (Baseline), Week 6 (Day 42 ± 3), and Week 12 (Day 84 ± 5) post-surgery
Corneal endothelial thickness
Changes from baseline in central corneal thickness (CCT; in microns)
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Postoperative Ocular Inflammation and Endothelial Outcomes
Postoperative ocular inflammation and endothelial outcomes will be assessed by evaluating the proportion of participants with absence of anterior chamber cells and flare (Grade 0), clinical cure (absence of both cells and flare)
Time frame: Week 1 (Day 7 ± 2) to Week 12 (Day 84 ± 5)
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