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Original Research

Ocular comfort assessment of lifitegrast ophthalmic solution 5.0% in OPUS-3, a Phase III randomized controlled trial

Kelly K Nichols1 School of Optometry, University of Alabama at Birmingham, Birmingham, AL

Edward Holland2 Cincinnati Eye Institute, Edgewood, KY

Melissa M Toyos3 Toyos Clinic, Nashville, TN

James H Peace4 United Medical Research Institute, Inglewood, CA

Parag Majmudar5 Chicago Cornea Consultants, Ltd., Hoffman Estates, IL

Aparna Raychaudhuri6 Shire, Lexington, MA, USA

Mohamed Hamdani6 Shire, Lexington, MA, USA

Monica Roy6 Shire, Lexington, MA, USA

Amir Shojaei6 Shire, Lexington, MA, USACorrespondence[email protected]

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Figures & data

Figure 1 Study design of OPUS-3.

Notes: Drop comfort was evaluated on days 0, 14, 42, and 84 with participant-reported assessments on a 0–10 scale (0 = very comfortable, 10 = very uncomfortable). All AEs were collected from the time the participant signed informed consent through the last study visit (day 84 or early termination).
Abbreviations: AE, adverse event; BID, twice daily.

Table 1 Demographic and baseline characteristics (randomized population)

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Figure 2 Drop comfort scores at 0–3 minutes postinstillation (safety population).

Notes: Drop comfort score (scale, 0–10; 0 = very comfortable, 10 = very uncomfortable); drop discomfort corresponds to scores >3. Scores between the study eye and fellow eye overlap.

Figure 3 Participants with drop comfort score <3 by visit (both eyes; safety population).

Notes: Safety population in each treatment group was used as a denominator in percentage calculation (lifitegrast, n=357; placebo, n=354). Drop comfort score (scale, 0–10; 0 = very comfortable, 10 = very uncomfortable).
Abbreviations: LIF, lifitegrast; PBO, placebo.

Figure 4 Drop comfort scores at 5, 10, and 15 minutes postinstillation among participants with drop comfort score >3 at 3-minute assessment (safety population; numbers above bars indicate participant numbers).

Note: Drop comfort score (scale, 0–10; 0 = very comfortable, 10 = very uncomfortable); drop discomfort corresponds to scores >3.

Table 2 Demographics and baseline characteristics of participants with drop comfort score >3 in the study eye at ≥15 minutes postinstillation (safety population)

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Figure 5 Incidence and severity of common ocular TEAEs (occurring in >5% in either treatment group; safety population).

Note: Verbatim Terms coding to instillation site irritation and instillation site reaction are described in the Methods section.
Abbreviations: LIF, lifitegrast; PBO, placebo; TEAE, treatment-emergent adverse event.

Ocular comfort assessment of lifitegrast ophthalmic solution 5.0% in OPUS-3, a Phase III randomized controlled trial

Table 1 Demographic and baseline characteristics (randomized population)

Table 2 Demographics and baseline characteristics of participants with drop comfort score >3 in the study eye at ≥15 minutes postinstillation (safety population)

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Ocular comfort assessment of lifitegrast ophthalmic solution 5.0% in OPUS-3, a Phase III randomized controlled trial

Figures & data

Table 1 Demographic and baseline characteristics (randomized population)

Table 2 Demographics and baseline characteristics of participants with drop comfort score >3 in the study eye at ≥15 minutes postinstillation (safety population)

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