Could a simple eye drop shield your cornea during cataract surgery?
NCT ID NCT07694375
First seen Jul 10, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study tests whether an investigational eye drop called CA201A can help protect the cornea from cell damage during cataract surgery. About 200 adults in Australia scheduled for cataract surgery will receive either CA201A or a placebo drop four times daily, starting a week before surgery and continuing for four weeks after. Researchers will measure changes in corneal endothelial cell density to see if the treatment preserves eye clarity and health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ascorbic acid ophthalmic solution 5%
- What this could lead to
- If effective, CA201A could become a simple eye drop that protects the cornea during cataract surgery, reducing the risk of long-term vision problems.
- What could go wrong
- This is an early-phase trial with only 200 participants, so results may not apply to everyone. The treatment may not work better than placebo, and eye drops can cause irritation or other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Adelaide Eye and Retina Centre
NOT_YET_RECRUITINGAdelaide, South Australia, 5000, Australia
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Canberra Eye Surgeons
NOT_YET_RECRUITINGDeakin, Australian Capital Territory, 2600, Australia
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Eastwood Eye Specialists
RECRUITINGEastwood, New South Wales, 2122, Australia
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Hobart Eye Surgeons
NOT_YET_RECRUITINGHobart, Tasmania, 7000, Australia
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Launceston Eye Doctors
NOT_YET_RECRUITINGLaunceston, Tasmania, 7250, Australia
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Nexus Eye Care Blacktown
NOT_YET_RECRUITINGBlacktown, New South Wales, 2148, Australia
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Nexus Eye Care Norwest
NOT_YET_RECRUITINGBaulkham Hills, New South Wales, 2153, Australia
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Sydney Retina Clinic & Day Surgery
RECRUITINGSydney, New South Wales, 2000, Australia
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