Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Sjogren's Syndrome; GVHD - Graft-Versus-Host Disease; Keratopathy

Treatments: Other: PBS eyedrops; Other: CBS eyedrops

Study type: Interventional

Funder types: Other

Identifiers

NCT03064984

100/2016/O/Sper

Details and patient eligibility

About

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

Full description

The rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (Growth factors, GF), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . The most used product so far is the eye drop prepared from serum (Autologous Serum, AS) or from platelet-rich plasma (Plasma Rich Platelet, PRP) of peripheral blood taken from the patients themselves. More recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. In particular the homologous sources show:

• not invasiveness to the patient, who could in time not like the repeated withdrawals

• applicability even in patients with underlying systemic conditions. They may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye

  • reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation
  • conceptually unlimited availability of the product to be dispensed
  • versatility of therapeutic indications, based on different GF levels which are estimated in advance

The purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of severe dry eye , scored as level severity 3 according to the Dry Eye WorkShop grade (DEWS, Ocular Surf 2007)
• corneal epithelial damage, stained with fluorescein as vital dye, NEI (national Eye Institute) score> 6 (estimated with imageJ software) damage coverage> 25% of total corneal area
• good general health condition
• ability to adhere to treatment and to the procedures provided by the study

Exclusion criteria

• concurrent treatment with hypotensive drugs
• ocular surgery in the 12 months preceding enrollment .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

CBS eyedrops

Active Comparator group

Description:

Eyedrops prepared from CBS (Cord Blood Serum), and administered 1 drop/each eye/8 times per day, for 30 days

Treatment:

Other: PBS eyedrops

PBS eyedrops

Active Comparator group

Description:

Eyedrops prepared from PBS (Peripheral Blood Serum) from adult donor subjects, administered 1 drop/each eye/8 times per day, for 30 days

Treatment:

Other: CBS eyedrops