Dry EyePhase 4CataClearNCT07191847
Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops
A Phase 4 study testing eye drops in people with Dry Eye and Cataract, run by Ace Cells Lab Limited at 1 site in Egypt.
Trial summary
Dry Eye Disease (DED) is a multifactorial condition that affects the ocular surface, leading to discomfort, tear film instability, and potential visual disturbances. Its global prevalence ranges between 5% and 50%, making it a significant cause of reduced quality of life and a growing burden on healthcare systems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2025to 1 Jan 2026
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years.
- Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results).
Who cannot join
- History of ocular surgery or trauma.
- Other ocular diseases (e.g., glaucoma, keratitis).
- Systemic conditions that may interfere with study outcomes (e.g., autoimmune diseases).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Alaa Abdelkarim DAF Fouad, MD, MBBCHConsultant stem cells contact
Dr. Shiren Amer, MSc, MBBCH consultant occupati contact
Egypt1 site, 1 recruiting
- Recruiting
British center for regenerative medicine
Giza, 335019
Dr. Sherine Amer, MD, +20 102 334 0300, shireen@ace-cells.co.uk
About this study
Official title: CaraClear, Studying Lens Peptides and Extra Ocular Tissue Managed by ACE Pico Protocol in Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops
Dry Eye Disease (DED) is a multifactorial condition that affects the ocular surface, leading to discomfort, tear film instability, and potential visual disturbances. Its global prevalence ranges between 5% and 50%, making it a significant cause of reduced quality of life and a growing burden on healthcare systems. Cataract, defined as a progressive opacification of the lens, remains the leading cause of preventable blindness worldwide, responsible for about 33% of all cases, affecting an estimated 94 million people. Its incidence increases with age and is influenced by factors such as ultraviolet exposure, diabetes, smoking, and genetic predisposition. Low- and middle-income countries (LMICs) face a disproportionately high burden due to limited access to surgical care. The economic impact of cataract is profound, including both direct costs (surgery, post-op care) and indirect costs (lost productivity, caregiver dependency), with global productivity losses estimated at $53 billion annually. Beyond economics, cataract significantly impairs quality of life, contributing to psychological distress, depression, loss of independence, and increased risk of cognitive decline. Addressing this burden requires integrated strategies that ensure equitable access to treatment, reduce financial barriers, and include psychosocial support. In parallel, emerging regenerative therapies such as stem cell-fortified eye drops offer new hope. These treatments, utilizing mesenchymal stem cells (MSCs), aim to restore ocular surface health in conditions like DED by reducing inflammation and enhancing tissue repair. The current study evaluates the efficacy of such drops in improving tear film stability, tear volume, and overall clinical symptoms using advanced diagnostic tools.
Read the detailed description
Dry eye disease (DED) is a multifactorial condition affecting the ocular surface, characterized by symptoms of discomfort, visual disturbances, tear film instability, and potential damage to the ocular surface. DED impacts patients' quality of life and poses a significant healthcare burden, with an estimated global prevalence ranging from 5% to 50%.
Cataract, a progressive opacification of the ocular lens leading to visual impairment, remains the foremost cause of preventable blindness globally, constituting a significant public health burden. According to the World Health Organization (WHO), an estimated 94 million individuals worldwide are affected by cataract-related visual disability, with the condition accounting for approximately 33% of all cases of blindness. The prevalence of cataract exhibits marked demographic and geographic heterogeneity, correlating strongly with advancing age, ultraviolet radiation exposure, metabolic disorders (e.g., diabetes mellitus), tobacco use, and genetic predisposition. While age-related cataracts dominate in populations over 50 years, congenital and traumatic forms contribute to morbidity across all age cohorts. Low- and middle-income countries (LMICs) bear a disproportionate burden, with cataract blindness rates up to threefold higher than in high-income regions due to limited access to surgical interventions and preventive care.
The socioeconomic ramifications of cataract-induced visual impairment are profound. Direct costs, including surgical expenses, postoperative care, and corrective devices, impose substantial financial strain on healthcare systems and households, particularly in resource-limited settings. Indirect costs, such as lost labor productivity, caregiver dependency, and reduced educational attainment, further exacerbate economic disparities. In LMICs, where out-of-pocket expenditures dominate healthcare financing, cost-related barriers delay surgical treatment, perpetuating cycles of disability and poverty. A meta-analysis estimated annual global productivity losses attributable to cataract at $53 billion, underscoring its macroeconomic impact.
Concurrently, cataract-associated visual decline engenders significant psychological morbidity. Patients frequently report diminished quality of life (QoL), characterized by heightened anxiety, depression, and social isolation due to functional limitations in daily activities (e.g., mobility, self-care). The loss of independence, particularly among elderly populations, exacerbates feelings of helplessness and stigmatization. Furthermore, delayed intervention correlates with irreversible neuroadaptive changes in the visual cortex, compounding psychological distress. Emerging evidence also highlights the bidirectional relationship between cataract-related disability and mental health disorders, with untreated visual impairment increasing susceptibility to cognitive decline and dementia.
Addressing the global cataract burden necessitates integrated strategies that combine equitable access to surgical care, cost-reduction initiatives, and psychosocial support systems. Understanding the interplay of epidemiological, economic, and mental health dimensions is critical to mitigating its multisectoral impact on human health and societal well-being.
Emerging therapies, including regenerative approaches like stem cell-fortified eye drops, show promise in addressing underlying pathophysiological mechanisms. These therapies leverage mesenchymal stem cells (MSCs) to promote ocular surface regeneration and repair by modulating inflammation and enhancing tissue healing.
This study aims to evaluate the efficacy of stem cell-fortified eye drops in improving tear film stability, tear volume, and clinical symptoms of DED, utilizing advanced diagnostic technologies for comprehensive assessments.
- Being tested
- eye drops
- Keywords
- dryeye, catclear
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye dropsBiological
apply 2 drops 3 times daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| corneal opacity clearing | Other | selecting the cases of corneal opacity and treat with 2 drops 3 times daily for 12 weeks Receives: Biological: eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit-lamp grading + AS-OCT (structural clarity)
Assess the therapeutic efficacy of stem cell-fortified eye drops in the corneal opacity
Measured: 12 weeks
Secondary outcomes (1)
BCVA (functional improvement)
detect corneal improvement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start22 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 2 drops in each eye 3 times daily
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ace Cells Lab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Mohammed Yasser Sayyed Saif, Prof of ophthalmology, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191847
- Sponsor's protocol ID
- BCRMED-Cat-002
- Acronym
- CataClear
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. outcome of the application of the drops with 2 weeks evaluation 2. any adverse effects
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CaraClear, Studying Lens Peptides and Extra Ocular Tissue Managed by ACE Pico Protocol in Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops
- ClinicalTrials.gov ID
- NCT07191847
- Acronym / sponsor ID
- CataClear / BCRMED-Cat-002
- Keywords
- dryeye, catclear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ace Cells Lab LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Nottingham
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
Dry Eye Disease (DED) is a multifactorial condition that affects the ocular surface, leading to discomfort, tear film instability, and potential visual disturbances. Its global prevalence ranges between 5% and 50%, making it a significant cause of reduced quality of life and a growing burden on healthcare systems. Cataract, defined as a progressive opacification of the lens, remains the leading cause of preventable blindness worldwide, responsible for about 33% of all cases, affecting an estimated 94 million people. Its incidence increases with age and is influenced by factors such as ultraviolet exposure, diabetes, smoking, and genetic predisposition. Low- and middle-income countries (LMICs) face a disproportionately high burden due to limited access to surgical care. The economic impact of cataract is profound, including both direct costs (surgery, post-op care) and indirect costs (lost productivity, caregiver dependency), with global productivity losses estimated at $53 billion annually. Beyond economics, cataract significantly impairs quality of life, contributing to psychological distress, depression, loss of independence, and increased risk of cognitive decline. Addressing this burden requires integrated strategies that ensure equitable access to treatment, reduce financial barriers, and include psychosocial support. In parallel, emerging regenerative therapies such as stem cell-fortified eye drops offer new hope. These treatments, utilizing mesenchymal stem cells (MSCs), aim to restore ocular surface health in conditions like DED by reducing inflammation and enhancing tissue repair. The current study evaluates the efficacy of such drops in improving tear film stability, tear volume, and overall clinical symptoms using advanced diagnostic tools.
Detailed description
Dry eye disease (DED) is a multifactorial condition affecting the ocular surface, characterized by symptoms of discomfort, visual disturbances, tear film instability, and potential damage to the ocular surface. DED impacts patients' quality of life and poses a significant healthcare burden, with an estimated global prevalence ranging from 5% to 50%.
Cataract, a progressive opacification of the ocular lens leading to visual impairment, remains the foremost cause of preventable blindness globally, constituting a significant public health burden. According to the World Health Organization (WHO), an estimated 94 million individuals worldwide are affected by cataract-related visual disability, with the condition accounting for approximately 33% of all cases of blindness. The prevalence of cataract exhibits marked demographic and geographic heterogeneity, correlating strongly with advancing age, ultraviolet radiation exposure, metabolic disorders (e.g., diabetes mellitus), tobacco use, and genetic predisposition. While age-related cataracts dominate in populations over 50 years, congenital and traumatic forms contribute to morbidity across all age cohorts. Low- and middle-income countries (LMICs) bear a disproportionate burden, with cataract blindness rates up to threefold higher than in high-income regions due to limited access to surgical interventions and preventive care.
The socioeconomic ramifications of cataract-induced visual impairment are profound. Direct costs, including surgical expenses, postoperative care, and corrective devices, impose substantial financial strain on healthcare systems and households, particularly in resource-limited settings. Indirect costs, such as lost labor productivity, caregiver dependency, and reduced educational attainment, further exacerbate economic disparities. In LMICs, where out-of-pocket expenditures dominate healthcare financing, cost-related barriers delay surgical treatment, perpetuating cycles of disability and poverty. A meta-analysis estimated annual global productivity losses attributable to cataract at $53 billion, underscoring its macroeconomic impact.
Concurrently, cataract-associated visual decline engenders significant psychological morbidity. Patients frequently report diminished quality of life (QoL), characterized by heightened anxiety, depression, and social isolation due to functional limitations in daily activities (e.g., mobility, self-care). The loss of independence, particularly among elderly populations, exacerbates feelings of helplessness and stigmatization. Furthermore, delayed intervention correlates with irreversible neuroadaptive changes in the visual cortex, compounding psychological distress. Emerging evidence also highlights the bidirectional relationship between cataract-related disability and mental health disorders, with untreated visual impairment increasing susceptibility to cognitive decline and dementia.
Addressing the global cataract burden necessitates integrated strategies that combine equitable access to surgical care, cost-reduction initiatives, and psychosocial support systems. Understanding the interplay of epidemiological, economic, and mental health dimensions is critical to mitigating its multisectoral impact on human health and societal well-being.
Emerging therapies, including regenerative approaches like stem cell-fortified eye drops, show promise in addressing underlying pathophysiological mechanisms. These therapies leverage mesenchymal stem cells (MSCs) to promote ocular surface regeneration and repair by modulating inflammation and enhancing tissue healing.
This study aims to evaluate the efficacy of stem cell-fortified eye drops in improving tear film stability, tear volume, and clinical symptoms of DED, utilizing advanced diagnostic technologies for comprehensive assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 drops in each eye 3 times daily
| Arm | Type | Receives |
|---|---|---|
| corneal opacity clearing | Other | Biological: eye dropsselecting the cases of corneal opacity and treat with 2 drops 3 times daily for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18-80 years.
- Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results).
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| eye dropsapply 2 drops 3 times daily for 12 weeks | Biological | corneal opacity clearing |
Primary outcome
Slit-lamp grading + AS-OCT (structural clarity)
Time frame: 12 weeks
Assess the therapeutic efficacy of stem cell-fortified eye drops in the corneal opacity
1 secondary outcome
BCVA (functional improvement)
Time frame: 12 weeks
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 25 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 1. outcome of the application of the drops with 2 weeks evaluation 2. any adverse effects
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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.
Dr. Alaa Abdelkarim DAF Fouad, MD, MBBCHConsultant stem cells contact
Dr. Shiren Amer, MSc, MBBCH consultant occupati contact
Mohammed Yasser Sayyed Saif, Prof of ophthalmology principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eye drops in people with Dry Eye and Cataract, run by Ace Cells Lab Limited at 1 site in Egypt.
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 2 inclusion and 3 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Dr. Alaa Abdelkarim DAF Fouad, MD, MBBCHConsultant stem cells (+447473922553, dralaa@ace-cells.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slit-lamp grading + AS-OCT (structural clarity) (time frame: 12 weeks). 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 25 Sep 2025.