Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops

NCT07191847 | Recruiting Phase 4 DMC

• 1 other identifier: BCRMED-Cat-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye; Cataract

Keywords

dryeye; catclear

Outcome Measures

Primary Outcomes (1)

• Slit-lamp grading + AS-OCT (structural clarity)

  Assess the therapeutic efficacy of stem cell-fortified eye drops in the corneal opacity

  12 weeks

Secondary Outcomes (1)

• BCVA (functional improvement)

  12 weeks

Study Arms (1)

corneal opacity clearing

OTHER

selecting the cases of corneal opacity and treat with 2 drops 3 times daily for 12 weeks

Biological: eye drops

Interventions

eye drops BIOLOGICAL

apply 2 drops 3 times daily for 12 weeks

corneal opacity clearing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years.
• Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ace Cells Lab Limited: lead
• University of Nottingham: collaborator

Study Sites (1)

British center for regenerative medicine

Giza, 335019, Egypt

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mohammed Yasser Sayyed Saif, Prof of ophthalmology

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 drops in each eye 3 times daily

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: September 25, 2025
• Study Start: April 22, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)