A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
brief 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.
detailed description
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).
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