Not Yet RecruitingPhase 2

Effect of PAE Hydrogel Loaded With tRF-ASO-Exo on Patients With Diabetic Ocular Surface Diseases

30 participantsStarted 2026-02-15

Plain-language summary

The purpose of this study is to determine whether poly（β-amino ester）(PAE)hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes(tRF-ASO-Exo) could alleviate symptoms in patients with diabetic ocular surface diseases(DOSD).

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Any past or current malignancy in or around the eye.
✕. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).
✕. Active ocular allergy now or expected during the study.
✕. Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics.
✕. Prior immunodeficiency, HIV, hep B/C, active hep A, organ or bone-marrow transplant.
✕. Any serious chronic illness the PI thinks could mess with endpoints-severe heart/lung disease, uncontrolled hypertension or diabetes.
✕. Blood donation or major blood loss within 8 weeks of screening.
✕. Active ocular rosacea, periorbital acne, or pterygium.

What they're measuring

corneal and conjunctival nerve density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Corneal sensitivity

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival goblet cell density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Staining

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival vessel density and number of branches

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Disease Index (OSDI) Score

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Trial details

NCT IDNCT07382453

SponsorAffiliated Hospital of Nantong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Min Ji

0513(81160554) amyji1234@hotmail.com

View on ClinicalTrials.gov More Diabetic Keratopathy trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Any past or current malignancy in or around the eye.
✕. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).
✕. Active ocular allergy now or expected during the study.
✕. Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics.
✕. Prior immunodeficiency, HIV, hep B/C, active hep A, organ or bone-marrow transplant.
✕. Any serious chronic illness the PI thinks could mess with endpoints-severe heart/lung disease, uncontrolled hypertension or diabetes.
✕. Blood donation or major blood loss within 8 weeks of screening.
✕. Active ocular rosacea, periorbital acne, or pterygium.

What they're measuring

corneal and conjunctival nerve density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Corneal sensitivity

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival goblet cell density

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Staining

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

conjunctival vessel density and number of branches

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks

Changes in Ocular Surface Disease Index (OSDI) Score

Timeframe: 1day, 2 weeks, 6 weeks, 12 weeks