Review Article

Human Serum Eye Drops in Eye Alterations: An Insight and a Critical Analysis

Table 3

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

Trial registration numberStudy typePatient numberBlood derivativesConditionsEnd-pointPhase

NCT01089985Interventional10ASXerophthalmiaEfficacy and safety of AS.Phase 1

NCT01972438Randomized
Intervention
Double-blind
44Autologous serum versus saline solutionHSCT patients with severe ocular GVHDTreatment of severe chronic ocular GVHD in HSCT patients unresponsive to standard medical treatment.Phase 1
Phase 2

NCT01075347Randomized
Intervention Assignment
Single-blind
165Human 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

NCT00681642Observational7Human autoserum versus cord blood serumCorneal epithelial defect, dry eye syndromeWound healing, cell proliferation and migration by means of wound healing assay evaluation, MTS assay, and Boyden chamber migration assay.Completed

NCT00442273Interventional
Nonrandomized
Double-blind
4820% autologous serum and umbilical cord serum eye dropsSevere dry eye syndromeTherapeutic effect between autologous serum and umbilical cord serum eye drops in the treatment of severe dry eye syndrome.Not provided

NCT00598299Observational
Prospective
100Human autoserum versus cord blood serumCorneal epithelial defect, dry eye syndromeCorneal wound healing assay evaluation, MTS assay, and Boyden chamber migration assay Completed

NCT01168375Intervention 80Umbilical cord serum Corneal epithelial defect following diabetic vitrectomyMeasurement of corneal epithelial defect in days 3, 5, 7, and 12 by slit lamp.Phase 1

NCT01016158Interventional
Randomized
Single-blind
NP20% umbilical cord serum eye dropsRecurrent corneal erosionEfficacy 20% umbilical cord serum eye drops.Completed

NCT01234623Randomized30Cord blood serumGVHD, Sjogren’s DiseaseHealing of corneal epithelial defects, ameliorating the painful subjective symptoms.Phase 1

NCT02291731Interventional
Single-blind
Not provided20% autologous serum eye drops and silicone-hydrogel contact lens (CLs)Corneal diseasesClinical 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

NCT01122303Observational 2020% autologous serum eye dropsSJS, nonautoimmune dry eyeComparisons 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

NCT00238862Randomized
single group Open label
180Autologous serum 20% versus amniotic membrane transplantation PEDCorneal reepithelialization, persistent corneal reepithelialization. Completed

NCT02153515Single group
Open label
60Autologous serum finger prick of blood Dry eyes, PED, ulcersUlcers 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

NCT00779987Interventional
study
Double-blind
1220% autologous serum solutionDry eyeScore 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-1: transforming growth factor 1; TGF-2: transforming growth factor 2; MTS: 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2Htetrazolium.