Comparative study to evaluate two different treatments for severe dry eye disease. Amniotic membrane extract versus autologous serum eyedrops.

Phase III comparative clinical trial to evaluate the efficacy of amniotic membrane extract for the treatment of severe dry eye disease, in comparison with autologous serum eyedrops.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006287-50-ES

Enrollment

Registered

2012-01-11

Start date

2015-04-01

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Severe Dry Eye Disease MedDRA version: 17.1 Level: LLT Classification code 10013778 Term: Dry eyes System Organ Class: 100000004853

Interventions

Product Name: Extracto de membrana amniótica Product Code: Extracto de membrana amniótica Pharmaceutical Form: Eye drops, suspension INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must be able to provide informed consent and express their desire tu fulfil every requirement during the study. Patients between 18 and 65 years old. Patients diagnosed with severe dry eye disease according to DEWS classification. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Systemic disease that can compromise patients participation in the study, according to investigator (hepatic failure, etc?) Previous ocular surgeries that can alter or modify the ocular surface (refractive surgery, palpebral surgery, corneal surgery) Patient is under systemic medication that can affect tear production. Contact lens wear. Pregnancy. Smoking. Concomitant palpebral pathology (lagoftalmos, exoftalmos, ectropion, etc?)

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the efficacy of topical amniotic membrane extract to treat symptoms of severe dry eye disease.; Secondary Objective: Determine product tolerance in the eye. Validate changes in tear osmolarimetry. Validate reduction of inflammatory response at the ocular surface. Compare results with autologous serum eyedrops. ; Primary end point(s): 1. Determine tear volume and clearance by Schirmer Test type I and FCT (Fluorescein Clearance test) according to Tseng technique (10, 20 and 30 minutes). 2. Determine tear stability by TBUT (tear break up time). 3. Ocular surface Impression cytology analysis: 3.1. goblet cells quantity. 3.2. HLA-DR expression. 3.3. MUC1 expression. ;Timepoint(s) of evaluation of this end point: 1,3 and 6 months	—

Measure

Time frame

Main Objective: To establish the efficacy of topical amniotic membrane extract to treat symptoms of severe dry eye disease.; Secondary Objective: Determine product tolerance in the eye. Validate changes in tear osmolarimetry. Validate reduction of inflammatory response at the ocular surface. Compare results with autologous serum eyedrops. ; Primary end point(s): 1. Determine tear volume and clearance by Schirmer Test type I and FCT (Fluorescein Clearance test) according to Tseng technique (10, 20 and 30 minutes). 2. Determine tear stability by TBUT (tear break up time). 3. Ocular surface Impression cytology analysis: 3.1. goblet cells quantity. 3.2. HLA-DR expression. 3.3. MUC1 expression. ;Timepoint(s) of evaluation of this end point: 1,3 and 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Tear osmolarity. 2. Symptoms subjective validation by OSDI questionnaire. 3. Product tolerance subjective validation by EVA (visual analogic scale). ;Timepoint(s) of evaluation of this end point: 1,3 and 6 months	—

Countries

Spain

Contacts

Public ContactUCICEC

Clínica Universidad de Navarra

ucicec@unav.es34948255 4002725

Outcome results

None listed

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