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

NCT07694375 | Recruiting Phase 2

• 1 other identifier: CA201A-P2-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Keywords

cataract surgery; corneal endothelial cell loss

Outcome Measures

Primary Outcomes (1)

• 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

  Visit 1: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery

Secondary Outcomes (7)

• Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  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

  Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery

• Incidence of Corneal Oedema Assessed by Slit Lamp Biomicroscopy

  Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery

• Intraocular Pressure (IOP) Measurements

  Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery

• Corneal endothelial cell morphology

  Day -7 ± 2 (Baseline), Week 6 (Day 42 ± 3), and Week 12 (Day 84 ± 5) post-surgery

Study Arms (2)

Vehicle (placebo)

PLACEBO COMPARATOR

Arm 1: Vehicle (placebo) ophthalmic solution - one drop 4 times daily (QID)

Drug: Ophthalmic solution (matching formulation without ascorbic acid)

Treatment (CA201A)

EXPERIMENTAL

Arm 2: CA201A ophthalmic solution one drop QID

Drug: Ascorbic acid ophthalmic solution 5%

Interventions

Ophthalmic solution (matching formulation without ascorbic acid) DRUG

Vehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid)

Vehicle (placebo)

Ascorbic acid ophthalmic solution 5% DRUG

Arm 2 - CA201A (ascorbic acid ophthalmic solution 5%)

Treatment (CA201A)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 using an ETDRS chart at 4 meters. The fellow eye must have visual acuity sufficient, in the opinion of the Investigator, to allow safe postoperative function.
• Female subjects must be of nonchildbearing potential or have a negative pregnancy test at Screening and agree to use appropriate contraception throughout the study.
• Male subjects with female partners of childbearing potential must agree to use appropriate contraception and refrain from sperm donation during the study.

You may not qualify if:

• 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).
• History of corneal transplantation or other corneal surgery.
• History of intraocular surgery in the study eye within 6 months of screening (except YAG laser capsulotomy \>3 months prior to screening).
• Planned combined cataract surgery with other intraocular procedures (eg, glaucoma surgery, vitrectomy).
• Active ocular infection or inflammation in either eye.
• Uncontrolled glaucoma (intraocular pressure \>25 mmHg on maximum tolerated medical therapy) in the study eye.
• Significant corneal opacity, scarring, or irregularity that would interfere with accurate specular microscopy assessment (including cases where image acquisition or analysis is not feasible).
• History of uveitis or other chronic inflammatory eye disease in the study eye.
• Proliferative diabetic retinopathy or active retinal disease in the study eye, that in the Investigator's opinion, may increase surgical risk or confound postoperative assessments.
• Any other ocular condition that, in the opinion of the Investigator, may interfere with study assessments or subject safety.
• History of corneal or retinal surgery (laser or incisional) in the study eye within 6 months, or planned ocular surgery during the study period.
• Presence of severe corneal guttae or other abnormalities in the study eye that, in the opinion of the Investigator, preclude reliable endothelial cell assessment by specular microscopy.

Sponsors & Collaborators

• Caravel Oculus Pty Ltd: lead

Study Sites (8)

Canberra Eye Surgeons

Deakin, Australian Capital Territory, 2600, Australia

NOT YET RECRUITING

Nexus Eye Care Norwest

Baulkham Hills, New South Wales, 2153, Australia

NOT YET RECRUITING

Nexus Eye Care Blacktown

Blacktown, New South Wales, 2148, Australia

NOT YET RECRUITING

Eastwood Eye Specialists

Eastwood, New South Wales, 2122, Australia

RECRUITING

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, 2000, Australia

RECRUITING

Adelaide Eye and Retina Centre

Adelaide, South Australia, 5000, Australia

NOT YET RECRUITING

Hobart Eye Surgeons

Hobart, Tasmania, 7000, Australia

NOT YET RECRUITING

Launceston Eye Doctors

Launceston, Tasmania, 7250, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Interventions

Ophthalmic Solutions; Ascorbic Acid

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Sandy Lai

CONTACT

+886227119697; sandylai@caraveloculus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

AU (8)