Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 85

CA201A Eye Drops to Protect the Cornea During Cataract Surgery

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

Run by Caravel Oculus Pty Ltd · NCT07694375 · Data updated 2026-11-12

This study tests whether CA201A eye drops can help protect corneal cells during cataract surgery in adults by comparing them to a non-active eye drop.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment200 (estimated)
SponsorCaravel Oculus Pty Ltd
Industry-sponsored
Locations8 sites (Deakin, Australian Capital Territory and 7 other locations)
StatusRecruiting
StartedJuly 28, 2026
Main results expectedJanuary 2027
Study endsFebruary 2027
Registry record updatedAugust 6, 2026
Trial IDNCT07694375 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–85 planning cataract extraction by phacoemulsification with posterior chamber IOL, meeting LOCS III criteria for nuclear cataract and able to comply with study procedures.

Probably not a fit

Patients with contraindications to ascorbic acid, significant ocular comorbidities, or those not meeting surgery or follow-up requirements may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multicenter, randomized, double-masked trial evaluates the safety and efficacy of CA201A, a 5% ascorbic acid ophthalmic solution, in preventing corneal endothelial cell loss after cataract surgery with phacoemulsification and intraocular lens implantation. Participants will start the eye drops 7 days before surgery, continue through 28 days post-operatively, and be followed for 12 weeks to assess safety and efficacy. The study uses a vehicle-controlled design so neither participants nor investigators know which eye drop is being given. Enrolling about 200 adults in Australia, the trial aims to determine whether CA201A reduces endothelial damage compared with the vehicle and whether it is well tolerated.

Why it matters

Potential benefit: If successful, CA201A could help preserve corneal endothelial cells after cataract surgery, potentially supporting better long-term corneal clarity.

How similar studies have gone: Prior similar approaches in ophthalmology have shown potential in protecting corneal tissue, but this exact CA201A strategy is novel in this surgical context.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 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.

Exclusion Criteria:

* Ocular Exclusions (Study Eye):
* 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.
* Anticipated complex cataract surgery in the study eye that, in the opinion of the Investigator, is likely to substantially increase endothelial injury risk or require nonstandard surgical techniques (eg, brunescent or hypermature cataract, significant zonular instability requiring planned capsular support devices, or other features expected to materially prolong phacoemulsification).
* Specular microscopy images that are not gradable at Screening despite repeat acquisition attempts.
* Systemic Exclusions:
* Known hypersensitivity to ascorbic acid or any component of the study drug or vehicle.
* Current use of systemic ascorbic acid supplementation (oral or intravenous) \>500 mg/day (Subjects taking ≤500 mg/day may continue their current regimen).
* History of calcium oxalate nephrolithiasis (kidney stones) within the past 5 years.
* Severe renal impairment (estimated glomerular filtration rate \<30mL/min/1.73 m²).
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency associated with clinically significant hemolytic risk.
* Pregnant or breastfeeding women.
* Females of childbearing potential unwilling to use acceptable contraception.
* Participation in another interventional clinical study or use of an investigational product within 6 weeks or 5 half-lives (whichever is longer) prior to study treatment. Observational studies and the use of over-the-counter vitamins or supplements are not exclusionary.
* Medical or psychiatric conditions that, in the opinion of the Investigator, would make consistent follow-up unlikely or pose an unacceptable medical risk.
* Clinically significant abnormalities in screening laboratory assessments (hematology, serum chemistry, or urinalysis), that, in the opinion of the Investigator, render the subject unsuitable for participation.

In general, subjects will be excluded if any of the following are present at screening:

* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 × upper limit of normal (ULN)
* Total bilirubin \>1.5 × ULN (unless consistent with Gilbert's syndrome)
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² Laboratory abnormalities not meeting the above thresholds may still be considered exclusionary if deemed clinically significant by the Investigator.

Where it's running

  • Eastwood Eye Specialists
    Eastwood, New South Wales, Australia
    Recruiting
  • Sydney Retina Clinic & Day Surgery
    Sydney, New South Wales, Australia
    Recruiting
  • Canberra Eye Surgeons
    Deakin, Australian Capital Territory, Australia
    Not yet recruiting
  • Nexus Eye Care Norwest
    Baulkham Hills, New South Wales, Australia
    Not yet recruiting
  • Nexus Eye Care Blacktown
    Blacktown, New South Wales, Australia
    Not yet recruiting
  • Adelaide Eye and Retina Centre
    Adelaide, South Australia, Australia
    Not yet recruiting
Show 2 more locations
  • Hobart Eye Surgeons
    Hobart, Tasmania, Australia
    Not yet recruiting
  • Launceston Eye Doctors
    Launceston, Tasmania, Australia
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.