A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5%, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance.
OBJECTIVE
To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance.


METHODS
Randomized, double-masked, placebo-controlled clinical trial.


METHODS
Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms.


RESULTS
In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported.


CONCLUSIONS
The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.
Pflugfelder
Stephen C
SC
Baylor College of Medicine, Houston, Texas, USA.
Maskin
Steven L
SL
Anderson
Bruce
B
Chodosh
James
J
Holland
Edward J
EJ
De Paiva
Cintia S
CS
Bartels
Stephen P
SP
Micuda
Teresa
T
Proskin
Howard M
HM
Vogel
Roger
R
D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003315:Cornea / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D019793:Fluorescein / Q000378:metabolism; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000188:drug therapy* / Q000378:metabolism*; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010865:Pilot Projects; D012449:Safety; D013194:Staining and Labeling / Q000379:methods; D013535:Suspensions; D013666:Tears / Q000378:metabolism*; D014065:Tonometry, Ocular; D014792:Visual Acuity
D000730:Androstadienes; D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D013535:Suspensions; D019793:Fluorescein; D000069559:Loteprednol Etabonate