Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of
the OPUS-1 phase 3 study.
Author(s): Sheppard JD(1), Torkildsen GL(2), Lonsdale JD(3), D'Ambrosio FA Jr(4), McLaurin
EB(5), Eiferman RA(6), Kennedy KS(7), Semba CP(8); OPUS-1 Study Group.
Collaborators: Correnti AJ, D'Ambrosio FA, Eiferman RA, Evans D, Geffin JA,
Greiner JV, Lonsdale JD, McLaurin EB, Nielsen SA, Torkildsen GL, Schumacher-Feero
LA, Sheppard JD, Spindel GP.
Affiliation(s): Author information:
(1)Virginia Eye Consultants and Eastern Virginia Medical School, Norfolk, Virginia.
(2)Andover Eye Associates, Andover, Massachusetts.
(3)Central Maine Eye Care, Lewiston, Maine.
(4)D'Ambrosio Eye Care, Lancaster, Massachusetts.
(5)Total Eye Care, Memphis, Tennessee.
(6)University of Louisville, Louisville, Kentucky.
(7)Independent Biostatistical Consultants, Tempe, Arizona.
(8)SARcode Bioscience, Inc, Brisbane, California. Electronic address:
csemba@shire.com.
Publication date & source: 2014, Ophthalmology. , 121(2):475-83
PURPOSE: To assess the efficacy and safety of lifitegrast ophthalmic solution
5.0% compared with placebo in subjects with dry eye disease.
DESIGN: Prospective, randomized, double-masked, placebo-controlled, parallel arm,
multicenter clinical trial.
PARTICIPANTS: A total of 588 adult subjects with dry eye disease.
METHODS: Eligible subjects were randomized 1:1 to receive topically administered
lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day
open-label placebo run-in period. After enrollment (day 0), subjects were
evaluated at days 14, 42, and 84. Key objective (fluorescein and lissamine
staining scores [Ora scales]) and subjective (Ocular Surface Disease Index
[OSDI], 7-item visual analog scale, and ocular discomfort score [Ora scale])
measures were assessed at all visits.
MAIN OUTCOME MEASURES: The primary objective efficacy measure (sign) was mean
change from baseline inferior corneal staining score (ICSS) at day 84. The
co-primary subjective efficacy measure (symptom) was the mean change from
baseline in the visual-related function subscale score of the Ocular Surface
Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores
(superior, central, total region) and conjunctival lissamine scores (nasal,
temporal, total region) and symptom scores at day 84.
RESULTS: The study met the primary objective efficacy ICSS end point in
demonstrating superiority of lifitegrast compared with placebo (P = 0.0007).
Lifitegrast significantly reduced corneal fluorescein staining (superior, P =
0.0392; total cornea, P = 0.0148) and conjunctival lissamine staining (nasal, P =
0.0039; total conjunctiva, P = 0.0086) at day 84 versus placebo. Significant (P <
0.05) improvements in nasal and total lissamine scores were observed at day 14
and maintained through day 84. The study did not meet the co-primary subjective
VR-OSDI measure (P = 0.7894). However, significant improvements were observed at
day 84 in ocular discomfort (P = 0.0273) and eye dryness (P = 0.0291), the most
common and severe symptoms reported at baseline in both groups. There were no
unanticipated or serious ocular adverse events (AEs). The most frequent reported
ocular AEs were transient intermittent instillation site symptoms (irritation,
discomfort) primarily on the initial lifitegrast dose at day 0.
CONCLUSIONS: Lifitegrast ophthalmic solution 5.0% significantly reduced corneal
fluorescein and conjunctival lissamine staining and improved symptoms of ocular
discomfort and eye dryness compared with placebo when administered twice daily
over 84 days.
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