Stem cell–fortified eye drops to improve tear stability and dry eye symptoms in people with cataract or dry eye
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
This will test stem cell‑fortified eye drops to improve tear film stability, increase tear volume, and ease dry eye symptoms in adults with dry eye disease, including those with cataract.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ace Cells Lab Limited Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Giza) |
| Trial ID | NCT07191847 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional protocol tests topical eye drops fortified with stem cell‑derived factors aimed at improving tear film stability, tear volume, and patient‑reported dry eye symptoms. Adults aged 18–80 with clinically diagnosed dry eye (for example by OSDI and Schirmer testing) receive the investigational drops and are followed for changes in objective tear metrics and symptom scores. Major exclusions include prior ocular surgery or trauma, other active ocular diseases (such as glaucoma or keratitis), and systemic conditions that could confound results. The trial is sponsored by Ace Cells Lab Limited in collaboration with the University of Nottingham and is listed at the British Center for Regenerative Medicine in Giza.
Who should consider this trial
Good fit: Adults aged 18–80 with a clinical diagnosis of dry eye disease (for example abnormal OSDI scores and reduced Schirmer test results) who do not have recent ocular surgery or other active eye diseases would be ideal candidates.
Not a fit: Patients with a history of ocular surgery or trauma, other active ocular diseases (e.g., glaucoma, keratitis), or systemic autoimmune conditions are excluded and unlikely to receive benefit from this intervention in the trial.
Why it matters
Potential benefit: If successful, these drops could reduce eye discomfort, stabilize the tear film, increase tear production, and improve daily vision and quality of life for people with dry eye.
How similar studies have performed: Early‑phase clinical and preclinical studies of cell‑derived or regenerative topical therapies have shown promising effects on tear quality and corneal healing, but robust large‑scale phase‑4 evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-80 years. * Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results). Exclusion Criteria: * Exclusion Criteria: * 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).
Where this trial is running
Giza
- British center for regenerative medicine — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohammed Yasser Sayyed Saif, Prof of ophthalmology — Beni-Suef University
- Study coordinator: Dr. Alaa Abdelkarim DAF Fouad, MD, MBBCHConsultant stem cells
- Email: dralaa@ace-cells.co.uk
- Phone: +447473922553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.