Dry Eye Syndrome Clinical Trial
Official title:
Allogenic Serum Micro Eye Drops Compared to Conventional Sized Eye Drops: A Prospective Randomized Non-inferiority, Investigator Masked, Cross-over Multicenter Clinical Study
Rationale: Serum eye drops (SEDs) are used to treat patients with severe signs and symptoms
of dry eyes and other corneal defects. Serum is used in severe ophthalmic cases where
conventional treatment and/or eye drops (artificial tears) have insufficient effect. The use
of SEDs in dry eye patients usually has a rapid effect. Most patients claim the effect to be
instantaneous, and most symptoms improve within 48-72 hours.
There is evidence suggesting that substances in serum may help in the healing of epithelial
defects, such as epidermal growth factor, fibroblast growth factor, fibronectin, and/or
vitamin A. However, the precise serum factor responsible for alleviating the patient's
complaints is currently not known.
SEDs are considered as a blood product under EU blood legislation (Directive 2002/98/EC), as
well as in New Zealand and Australia. Commonly, autologous SEDs are used, but they are
replaced more and more by allogeneic SEDs prepared from donor serum. Allogeneic SEDs are
derived from healthy voluntary, non-remunerated male donors with blood group AB, and have the
benefit of blood bank controlled quality. They can be delivered from stock and are therefore
quickly available for each patient.
For application of eye drops, generally administration systems with a drop size of 40 to 50
µl are used, further on referred to as conventional sized eye drops. From previous studies
done with medicinal eye drops, it has been shown that smaller eye drops, so called micro
drops, can be just as effective and sometimes even superior to conventional drops for
treatment of eye disease. If micro drops are just as effective or maybe even superior to
conventional sized eye drops is currently unknown for the use of SEDs. This study will
compare the feasibility and effectiveness of allogeneic serum micro eye drops using the
mu-Drop applicator to the conventional sized allogeneic eye drops using the Meise applicator.
Both systems have a closed manufacturing system.
Objective: The main objective is to determine whether the administration of allogeneic serum
micro eye drops is non-inferior in terms of effectiveness and safety as compared to the
conventional sized drops.
Main study parameters/endpoints: The primary endpoint is the improvement in OSDI score by
using SEDs (OSDI score after treatment minus OSDI score before treatment), independent of the
drop size, showing non-inferiority for the use of micro drops as compared to conventional
sized drops.
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