Corneal Endothelial Cell LossPhase 2NCT07694375
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
A Phase 2 study testing Ophthalmic solution (matching formulation without ascorbic acid) and Ascorbic acid ophthalmic solution 5% in people with Corneal Endothelial Cell Loss and Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery, run by Caravel Oculus Pty Ltd at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
- What is being tested?
- Ophthalmic solution (matching formulation without ascorbic acid) and Ascorbic acid ophthalmic solution 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesAustralia
- Study dates
- 28 Jul 2026to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Australia8 sites, 8 recruiting
- Not yet recruiting
Adelaide Eye and Retina Centre
Adelaide, South Australia, 5000
A/Prof Jagjit Gilhotra, jsgilhotra@gmail.com
A/Prof Jagjit Gilhotra
- Not yet recruiting
Nexus Eye Care Norwest
Baulkham Hills, New South Wales, 2153
Dr Anagha Vaze, +61435539976, anagha.vaze@gmail.com
Prof Chameen Samarawickrama
- Not yet recruiting
Nexus Eye Care Blacktown
Blacktown, New South Wales, 2148
Dr Anagha Vaze, +61435539976, anagha.vaze@gmail.com
Prof Chameen Samarawickrama
- Not yet recruiting
Canberra Eye Surgeons
Deakin, Australian Capital Territory, 2600
Dr Geoffrey Broadhead, gbro8081@uni.sydney.edu.au
Dr Geoffrey Broadhead
- Recruiting
Eastwood Eye Specialists
Eastwood, New South Wales, 2122
Dr John Chang, +61281882020, john@eastwoodeye.com.au
Dr John Chang
- Not yet recruiting
Hobart Eye Surgeons
Hobart, Tasmania, 7000
Tim Traill, +61362106000, tim.traill@eyesurgeons.com.au
Prof Nitin Verma
- Not yet recruiting
Launceston Eye Doctors
Launceston, Tasmania, 7250
Dr Andrew Patrick, +61363340000, apatrick@launcestoneyedoctors.com.au
Dr Tze'Yo Toh
- Recruiting
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales, 2000
Prof Andrew Chang, +61292213755, achang@sydneyretina.com.au
Prof Andrew Chang
About this study
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
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.
Read more
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.
Read the 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).
- Conditions
- Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
- Being tested
- Ophthalmic solution (matching formulation without ascorbic acid), Ascorbic acid ophthalmic solution 5%
- Keywords
- cataract surgery, corneal endothelial cell loss
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic solution (matching formulation without ascorbic acid)Drug
Vehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid)
Ascorbic acid ophthalmic solution 5%Drug
Arm 2 - CA201A (ascorbic acid ophthalmic solution 5%)
| Study group | Role | What they receive |
|---|---|---|
| Vehicle (placebo) | Placebo comparator | Arm 1: Vehicle (placebo) ophthalmic solution - one drop 4 times daily (QID) Receives: Drug: Ophthalmic solution (matching formulation without ascorbic acid) |
| Treatment (CA201A) | Experimental | Arm 2: CA201A ophthalmic solution one drop QID Receives: Drug: Ascorbic acid ophthalmic solution 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Week 1 (Day 7 ± 2) to Week 12 (Day 84 ± 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start28 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caravel Oculus Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694375
- Sponsor's protocol ID
- CA201A-P2-01
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07694375
- Acronym / sponsor ID
- CA201A-P2-01
- Conditions
- Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
- Keywords
- cataract surgery, corneal endothelial cell loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Caravel Oculus Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle (placebo) | Placebo comparator | Drug: Ophthalmic solution (matching formulation without ascorbic acid)Arm 1: Vehicle (placebo) ophthalmic solution - one drop 4 times daily (QID) |
| Treatment (CA201A) | Experimental | Drug: Ascorbic acid ophthalmic solution 5%Arm 2: CA201A ophthalmic solution one drop QID |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (33 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic solution (matching formulation without ascorbic acid)Vehicle (placebo) ophthalmic solution (matching formulation without ascorbic acid) | Drug | Vehicle (placebo) |
| Ascorbic acid ophthalmic solution 5%Arm 2 - CA201A (ascorbic acid ophthalmic solution 5%) | Drug | Treatment (CA201A) |
Primary outcome
Change in central corneal endothelial cell density associated with cataract surgery
Time frame: Visit 1: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-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
7 secondary outcomes
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Incidence of Corneal Oedema Assessed by Slit Lamp Biomicroscopy
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Intraocular Pressure (IOP) Measurements
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Corneal endothelial cell morphology
Time frame: Day -7 ± 2 (Baseline), Week 6 (Day 42 ± 3), and Week 12 (Day 84 ± 5) post-surgery
Corneal endothelial thickness
Time frame: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery
Postoperative Ocular Inflammation and Endothelial Outcomes
Time frame: Week 1 (Day 7 ± 2) to Week 12 (Day 84 ± 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ophthalmic solution (matching formulation without ascorbic acid) and Ascorbic acid ophthalmic solution 5% in people with Corneal Endothelial Cell Loss and Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery, run by Caravel Oculus Pty Ltd at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Lai (+886227119697 ext. 26, sandylai@caraveloculus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central corneal endothelial cell density associated with cataract surgery (time frame: Visit 1: Day -7 ± 2 (Baseline) to Week 12 (Day 84 ± 5) post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.