Clinical Trials CELab

Controlled Environment Laboratory

What is CELab?

The Controlled Environment Laboratory (CELab) is a unique facility composed of an exposure chamber, an evaluation chamber, and all the experience of the Institute of Applied Ophthalmobiology (IOBA) of the University of Valladolid.

Why you should use CELab?

Financial resources for carrying out clinical trials are increasingly limited, however, time-to-market pressure is also growing, and consequently, selecting the appropriate partner is the key to success. The CELab of VISION R&D, where environmental conditions are tightly controlled, offers cutting edge technology to carry out high quality research and clinical trials.

The CELab benefits are:

1. More reliable diagnostic test values that reduce the number of subjects necessary to obtain statistically significant results

2. By running a large amount of evaluation tests and biomarkers, the efficacy of the potential therapeutic candidate is widely defined

3. The most valid end-points can be selected for further multicenter clinical trials, eliminated those that showed no signal

4. Ability to obtain a “yes/no” answer before running a large sample of patients for multicenter clinical trials with registration purposes

5. Increases speed and saves economical resources in drug development, registration, and commercialization programs

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CLINICAL ASSESSMENT

Symptom and quality of life assesment
Ocular surface integrity
Tear film evaluation
High and low contrast visual acuity
Corneal topography and ocular aberrometry
Non-contact esthesiometry (chemical, mechanical, thermal)
In-vivo confocal microscopy
Oculo facial pain assessment

 

CLINICAL TRIALS UNIT

Experienced highly trained interdisciplinary personnel
Protocol design
Patient recruitment
Final report

 

LABORATORY EVALUATION

Immunological assays
Tear film and cellular biomarkers
Brush and impression cytologies
Tear and cellular analysis (gene and protein)

 

BIOSTATISTICS

Statistical analysis (protocol design, data analysis and assessment)