Trial Outcomes & Findings for Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis (NCT NCT00882687)

Results Overview

Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline to Day 7 (7 minutes post CAC 6)

Results posted on

2021-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lifitegrast 0.1%	Lifitegrast 1.0%	Lifitegrast 5.0%	Placebo
Overall Study STARTED	15	15	15	15
Overall Study COMPLETED	13	13	12	13
Overall Study NOT COMPLETED	2	2	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifitegrast 0.1% n=15 Participants	Lifitegrast 1.0% n=15 Participants	Lifitegrast 5.0% n=15 Participants	Placebo n=15 Participants	Total n=60 Participants Total of all reporting groups
Age, Continuous	41.67 years STANDARD_DEVIATION 15.207 • n=5 Participants	37.67 years STANDARD_DEVIATION 12.613 • n=7 Participants	45.33 years STANDARD_DEVIATION 15.891 • n=5 Participants	39.13 years STANDARD_DEVIATION 12.212 • n=4 Participants	40.95 years STANDARD_DEVIATION 14.019 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	31 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Day 7 (7 minutes post CAC 6)

Population: Intent-to-treat (ITT) population with last observation carried forward (LOCF)

Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.