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. 2015 Oct 4;2015:396410. doi: 10.1155/2015/396410

Table 3.

Ongoing controlled clinical studies on serum eye drops from ClinicalTrials.gov.

Trial registration number Study type Patient number Blood derivatives Conditions End-point Phase
NCT01089985 Interventional 10 AS Xerophthalmia Efficacy and safety of AS. Phase 1

NCT01972438 Randomized
Intervention
Double-blind
44 Autologous serum versus saline solution HSCT patients with severe ocular GVHD Treatment of severe chronic ocular GVHD in HSCT patients unresponsive to standard medical treatment. Phase 1
Phase 2

NCT01075347 Randomized
Intervention Assignment
Single-blind
165 Human autoserum versus traditional medications (0.1% betamethasone, 0.3% gentamicin, and 0.4% tropicamide eye drops) Corneal epithelial defect,
diabetic retinopathy,
penetrating keratoplasty
Corneal epithelial healing time by slit-lamp examination with fluorescein staining. Phase 1

NCT00681642 Observational 7 Human autoserum versus cord blood serum Corneal epithelial defect, dry eye syndrome Wound healing, cell proliferation and migration by means of wound healing assay evaluation, MTS assay, and Boyden chamber migration assay. Completed

NCT00442273 Interventional
Nonrandomized
Double-blind
48 20% autologous serum and umbilical cord serum eye drops Severe dry eye syndrome Therapeutic effect between autologous serum and umbilical cord serum eye drops in the treatment of severe dry eye syndrome. Not provided

NCT00598299 Observational
Prospective
100 Human autoserum versus cord blood serum Corneal epithelial defect, dry eye syndrome Corneal wound healing assay evaluation, MTS assay, and Boyden chamber migration assay Completed

NCT01168375 Intervention 80 Umbilical cord serum Corneal epithelial defect following diabetic vitrectomy Measurement of corneal epithelial defect in days 3, 5, 7, and 12 by slit lamp. Phase 1

NCT01016158 Interventional
Randomized
Single-blind
NP 20% umbilical cord serum eye drops Recurrent corneal erosion Efficacy 20% umbilical cord serum eye drops. Completed

NCT01234623 Randomized 30 Cord blood serum GVHD, Sjogren's Disease Healing of corneal epithelial defects, ameliorating the painful subjective symptoms. Phase 1

NCT02291731 Interventional
Single-blind
Not provided 20% autologous serum eye drops and silicone-hydrogel contact lens (CLs) Corneal diseases Clinical effect of combination of topical 20% autologous serum eye drops and CLs in the treatment of recalcitrant PEDs and the recurrence rate of epithelial breakdown with or without continued use of autologous serum eye drops for 2 weeks after total reepithelialization. Currently recruiting

NCT01122303 Observational 20 20% autologous serum eye drops SJS, nonautoimmune dry eye Comparisons of the concentrations of EGF, TGF-β1, TGF-β2, and fibronectin in 20% AS between SJS patients with dry eye and nonautoimmune dry eye patients. Unknown

NCT00238862 Randomized
single group Open label
180 Autologous serum 20% versus amniotic membrane transplantation PED Corneal reepithelialization, persistent corneal reepithelialization. Completed

NCT02153515 Single group
Open label
60 Autologous serum finger prick of blood Dry eyes, PED, ulcers Ulcers time healing (within 4 weeks)
Improving of corneal and conjunctival staining, Schirmer's test, tear break-up time, or symptoms ocular comfort index questionnaire (dry eyes).
Phase 3

NCT00779987 Interventional
study
Double-blind
12 20% autologous serum solution Dry eye Score reduction in the OSDI between patients treated with autologous serum and conventional artificial tears. Phase 2

HCST: hematopoietic stem cell transplant; GVHD: chronic graft versus host disease; CLs: silicone-hydrogel contact lens; CLs: silicone-hydrogel contact lens; PED: persistent epithelial defects; SJS: Steven Johnson Syndrome; OSDI: Ocular Surface Disease Index; EGF: epidermal growth factor; TGF-β1: transforming growth factor β1; TGF-β2: transforming growth factor β2; MTS: 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2Htetrazolium.