Clinical trials of therapeutic ocular surface medium for moderate to severe dry eye.
OBJECTIVE
To investigate therapeutic ocular surface medium (TOSM), a potential physiological tear replacement therapy, for moderate to severe dry eye.


METHODS
Forty-six patients with symptoms of moderate to severe dry eye despite maximal standard therapy were enrolled in a prospective pilot study of TOSM over 1 month (n = 10) and a randomized, double-masked, controlled trial of TOSM versus saline (placebo) over 2 months (n = 36). The primary outcome measure was conjunctival rose bengal staining.


RESULTS
An improvement in conjunctival rose bengal staining by ≥3 points occurred in 7 of 10 patients receiving TOSM in the pilot study (P = 0.017) and in 8 of 18 patients (44%) in the randomized trial (P = 0.982). In the pilot study, subjective dry eye symptoms significantly improved (P = 0.005). TOSM significantly improved the blepharitis score (P = 0.002) and conjunctival impression cytology (P = 0.028) in the randomized controlled trial. There were no serious or irreversible side effects with TOSM.


CONCLUSIONS
TOSM is a physiological tear replacement for dry eye that, unlike autologous serum, can be easily manufactured, could be widely available, and may also be beneficial for blepharitis.
Watson
Stephanie L
SL
Cornea and External Diseases, Moorfields Eye Hospital, London, United Kingdom. s.watson@unsw.edu.au
Daniels
Julie T
JT
Geerling
Gerd
G
Dart
John Kg
JK
D000328:Adult; D000368:Aged; D001762:Blepharitis / Q000188:drug therapy / Q000473:pathology; D002470:Cell Survival / Q000187:drug effects; D003228:Conjunctiva / Q000473:pathology; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D005260:Female; D005456:Fluorescent Dyes; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000627:therapeutic use*; D010865:Pilot Projects; D011446:Prospective Studies; D012395:Rose Bengal; D012720:Severity of Illness Index; D013194:Staining and Labeling; D055815:Young Adult
D005456:Fluorescent Dyes; D009883:Ophthalmic Solutions; D012395:Rose Bengal