Study that will compare a tear substitute (Siccafluid) with autologous serum (from the blood of the subject) in the pathology of dry eye, according to a plan that neither the doctor nor the patient will know which treatment the patient is assigned.

Study Prospective Randomized Controlled Double-Blind: Comparison of tear substitute (Siccafluid) and Autologous Serum in Dry Eye Disease - Siccafluid and autologous serum

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004605-27-IT

Enrollment

Unknown

Registered

2012-10-25

Start date

2012-11-05

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye disease MedDRA version: 14.1 Level: LLT Classification code 10018728 Term: Gritty eyes System Organ Class: 100000004853

Interventions

Trade Name: SICCAFLUID*GEL OFT 10G 2,5MG/G Pharmaceutical Form: Eye gel INN or Proposed INN: Belzalconio cloruro, sorbitolo, lisina monoidrata, sodio acetato triidrato, polivinile alcool Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 - Presence of altered cornea (punctate keratopathy) and / or conjunctival least grade I ° according to the classification scheme of Oxford (Annex A) after staining with fluorescein to the cornea and conjunctiva with lissamine green for. 2 - Tear break-up time fluorescein =65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: a. duct obstruction of the lacrimal gland b. causes of increased tear evaporation causes intrinsic c. Systemic use of drugs that could affect the tear film, tear secretion or the surface area of ??the eye (eg pilocarpine). d. The use of previous or concurrent topical medications that may affect the evaluation of the drug's and. History of previous ocular surgery, including refractive surgery, eyelid surgery or corneal surgery. f. extrinsic causes (disorders of the ocular surfaces, use of contact lenses, allergic conjunctivitis) g. Contraindications to the use of autologous serum: Hemoglobinopathies with high levels of bilirubin, viral and fungal infections bacterial active; Paraproteinemie; postivi Serology tests (HIV, HCV, HBV). h. Age <18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess which of the two treatments results in a greater improvement in objective signs of dry eye in a month (improvement of at least 2 degrees of the scale of Oxford).;Secondary Objective: Assess which of the two treatments results in a greater improvement in subjective signs of dry eye in a month. Assessing whether there is a difference in response to therapy based on the severity of symptoms at baseline and between the two groups (group artificial tears and autologous serum) that within the same treatment group. Assessing whether there is a difference in response to therapy according to the different pathological condition that determines the dry eye is between the two groups (the group artificial tears and autologous serum) that within the same group of therapy. Determine the efficacy and safety of topical treatment with autologous serum in dry eye disease.;Primary end point(s): improvement of at least 2 degrees of the scale of Oxford;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: Assess which of the two treatments results in a greater improvement in objective signs of dry eye in a month (improvement of at least 2 degrees of the scale of Oxford).;Secondary Objective: Assess which of the two treatments results in a greater improvement in subjective signs of dry eye in a month. Assessing whether there is a difference in response to therapy based on the severity of symptoms at baseline and between the two groups (group artificial tears and autologous serum) that within the same treatment group. Assessing whether there is a difference in response to therapy according to the different pathological condition that determines the dry eye is between the two groups (the group artificial tears and autologous serum) that within the same group of therapy. Determine the efficacy and safety of topical treatment with autologous serum in dry eye disease.;Primary end point(s): improvement of at least 2 degrees of the scale of Oxford;Timepoint(s) of evaluation of this end point: 1 month

—

Secondary

Measure	Time frame
Secondary end point(s): improvement of at least 2 degrees of the scale of Oxford for both treatments;Timepoint(s) of evaluation of this end point: 1 month	—

Countries

Italy

Contacts

Public ContactS.C. di Oculistica

Azienda Ospedaliera Arcispedale S. Maria Nuova

marchi.sylvia@asmn.re.it0522 295397

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

Study that will compare a tear substitute (Siccafluid) with autologous serum (from the blood of the subject) in the pathology of dry eye, according to a plan that neither the doctor nor the patient will know which treatment the patient is assigned.

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results