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

ConditionsDry EyeCataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAce Cells Lab Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-80 years.

Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results).

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • eye drops

    Biological/Vaccine

    apply 2 drops 3 times daily for 12 weeks

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: corneal opacity clearingOther 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
12 weeks

Secondary outcomes

1

BCVA (functional improvement)

detect corneal improvement

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ace Cells Lab Limited

Lead sponsor

University of Nottingham

Collaborator