AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Conditions the study is for
Dry Eye, Cataract
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

+447473922553

dralaa@ace-cells.co.uk

Dr. Shiren Amer, MSc, MBBCH consultant occupati contact

+20 102 334 0300

Egypt1 site, 1 recruiting
  • British center for regenerative medicine

    Giza, 335019

    Dr. Sherine Amer, MD, +20 102 334 0300, shireen@ace-cells.co.uk

    Recruiting

Other trials in Egypt

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.

Conditions
Dry Eye, Cataract
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 groups in NCT07191847
Study groupRoleWhat they receive
corneal opacity clearingOtherselecting 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.

  1. 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)
  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.

  1. First posted25 Sep 2025
  2. Study start22 Apr 2025
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in