Actively Recruiting
CaraClear Evaluating Stem Cell-Fortified Eye Drops for Tear Film Stability, Tear Volume, and Dry Eye Symptoms in Cataract and Dry Eye Disease
Led by Ace Cells Lab Limited · Updated on 2025-09-25
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
Ace Cells Lab Limited
Lead Sponsor
U
University of Nottingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
Dry Eye Disease (DED) is a condition affecting the surface of the eye, causing discomfort, unstable tear film, and possible vision problems. Cataract, a clouding of the eye's lens, is the leading cause of preventable blindness worldwide, affecting millions and linked to aging and factors like UV exposure and diabetes. This research evaluates stem cell-fortified eye drops as a potential new treatment to improve tear film stability, tear volume, and symptoms in people with DED, using advanced diagnostic tools. Participants in this study will receive eye drops containing mesenchymal stem cells. The treatment involves applying two drops three times daily for 12 weeks to cases with corneal opacity. The study focuses on assessing changes in eye structure clarity and visual function over this period. The study is interventional, with no masking or blinding, and targets adults aged 18 to 80 years. During the study, participants will be monitored through slit-lamp grading and anterior segment optical coherence tomography (AS-OCT) at 12 weeks to measure structural clarity. Visual acuity will also be evaluated to assess functional improvement. The research aims to understand the potential benefits of these eye drops on eye health and symptoms, with safety and symptom changes tracked throughout the treatment period.
CONDITIONS
Brief Title
Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Diagnosed with dry eye disease based on clinical criteria such as OSDI scores and Schirmer test results
You will not qualify if you...
- History of ocular surgery or trauma
- Presence of other ocular diseases like glaucoma or keratitis
- Systemic conditions that may affect study outcomes, such as autoimmune diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants apply 2 drops of stem cell-fortified eye drops 3 times daily to treat dry eye disease and corneal opacity.
Regular visits during the 12-week treatment period
Trial Site Locations
Total: 1 location
1
British center for regenerative medicine
Giza, Egypt, 335019
Actively Recruiting
Research Team
D
Dr. Alaa Abdelkarim DAF Fouad, MD, MBBCHConsultant stem cells
D
Dr. Shiren Amer, MSc, MBBCH consultant occupati
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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