Purpose. To determine the efficacy and safety of topical autologous serum a
s a treatment of dry eye patients. Methods. A 2-month, prospective, single-
masked, placebo-controlled study was conducted in patients with bilateral s
evere dry eye. One eye was randomized to receive the patient's own serum as
a tear substitute, and the fellow eye received unpreserved normal saline s
olution as a placebo. Subjective symptoms and clinical parameters of dry ey
e including conjunctival impression cytology were assessed at baseline and
1 week, 1 month, and 2 months after treatment. Results. Twelve dry eye pati
ents were enrolled. Both subjective symptoms (discomfort, foreign-body sens
ation, dryness, and photophobia), objective signs (fluorescein and rose ben
gal staining and conjunctival impression cytology) improved significantly i
n treated eyes compared with baseline. Control eyes also had improvement in
symptoms, signs, and rose bengal staining compared with baseline. Neither
Schirmer test results nor tear break-up time improved in either group. The
means score of all parameters were improved in both groups, and the results
of conjunctival impression cytology were better in treated eyes; however,
these results are not significantly different. There were no serious advers
e effects observed in this study. Conclusions. There was a trend toward imp
rovement in symptoms and signs of dry eye including cytologic changes after
application of autologous serum in severe dry eve patients. However, this
trend was not statistically significant., larger scale study is warranted.