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C CLINICAL RESEARCH

Drop comfort assessment in OPUS-3, a phase 3 randomized controlled trial of lifitegrast
ophthalmic solution 5.0% for dry eye disease

B Caffery, OD, PhD1; K Nichols, OD, PhD2; E Holland, MD3; M Toyos, MD4; J Peace, MD5; P
Majmudar, MD6; A Raychaudhuri, PhD7; M Roy, OD, MPH7; A Shojaei, PharmD, PhD7
1Toronto Eye Care, Toronto, ON, Canada; 2University of Alabama at Birmingham, Birmingham, AL,
USA; 3Cincinnati Eye Institute, Edgewood, KY, USA; 4Toyos Clinic, Nashville, TN, USA; 5United
Medical Research Institute, Inglewood, CA, USA; 6Chicago Cornea Consultants, Ltd., Hoffman
Estates, IL, USA; 7Shire, Lexington, MA, USA.

PURPOSE
Lifitegrast is a small molecule integrin antagonist that targets inflammation in dry eye disease (DED) by blocking
interaction of lymphocyte function-associated antigen 1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1).
We report drop comfort score of lifitegrast ophthalmic solution 5.0% (LIF) in OPUS-3, an efficacy/safety trial of LIF
versus placebo (PBO) in patients with DED.

METHODS
OPUS-3 was a 12-week, prospective, randomized, multicenter, double-masked, PBO-controlled study conducted
in the US (NCT02284516). After a 2-week PBO run-in, adults with DED (Schirmer Tear Test =1 and =10 mm in =1
eye, eye dryness score [visual analogue scale 0–100, single score for both eyes] =40, corneal staining score =2.0 (0-4
scale) in =1 region in =1 eye, and recent artificial tear use were randomized to LIF or PBO in a 1:1 ratio twice-daily
for 84 days. On days 0 (baseline), 14, 42, and 84 (visits 2–5), drop comfort score (DC, 0–10 scale; 0=very comfortable,
10=very uncomfortable) of both eyes was evaluated at 0, 1, 2, and 3 min post instillation. If DC was >3 at 3 min, as-
sessment was repeated at 5, 10 and 15 min until DC =3.

R E S U LT S
Overall, 711 subjects (LIF, n=357; PBO, n=354) were included. Numeric improvements in mean DC of the study eye
at instillation were observed across visits in LIF-treated subjects (baseline, LIF group 4.4, PBO group 1.2; day 14, LIF
4.0, PBO 1.4; day 42, LIF 3.5, PBO 1.1; day 84, LIF 3.4, PBO 1.0). On days 14, 42 and 84, respectively, 66%, 64% and 64%
of LIF-treated subjects reported DC <3 at 3 min post instillation. In subjects reassessed for DC at 5, 10 or 15 min,
the mean score in LIF-treated subjects was similar to or better than that in the PBO group at the same time points.

CONCLUSIONS
Initial DC in LIF-treated subjects showed improvements within 3 min of instillation and consistent reductions
across visits.

CONFLICT OF INTEREST DISCLOSURE
This study was funded by Shire. The authors thank Nasser Malik, PhD, of Excel Scientific Solutions, who provided
medical writing assistance funded by Shire.

Barbara Caffery has received consulting fees from Shire, Allergan and Santen.

Kelly K. Nichols has received research funding from Allergan, Eleven Biotherapeutics, Kala, NIH, Shire/SARcode,
TearScience, and Vistakon and has been a consultant for Allergan, InSite, Kala, Parion, Shire/SARcode, Sun, Sci-
enceBased Health, and Santen.

Edward Holland has received research funding from Alcon Laboratories, Inc., Allergan, Mati Therapeutics, Omeros,
PRN, and Senju Pharaceuticals, and has been a consultant for Alcon Laboratories, Inc., Allergan, Bausch & Lomb,
Kala Pharmaceuticals, Mati Therapeutics, Omeros, PRN, RPS, Senju Pharaceuticals, Shire/SARcode, TearLab, and
TearScience. In addition, Dr. Holland has been a speaker for Alcon Laboratories, Inc., Allergan, Bausch & Lomb,
Omeros, Senju Pharaceuticals, Shire/SARcode, and TearScience.

Melissa Toyos has received research funding from DigiSight, INC Research Ocular Therapeutix, Kala, Paraxel, PRN,
Shire, Bausch and Lomb (Valeant), and has been a speaker for Alcon, Bausch and Lomb (Valeant), Shire and Sun. Dr.
Toyos has been a consultant and speaker for Allergan.

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