Trial Outcomes & Findings for Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis (NCT NCT02079649)

Results Overview

Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

224 participants

Primary outcome timeframe

0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Results posted on

2015-08-24

Participant Flow

Subjects were recruited from 1 study center located in the US.

Of the 224 enrolled, 60 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects. Note: 2 randomized subjects were exited prior to treatment.

Participant milestones

Participant milestones
Measure	AL-78843 One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	AL-53817 One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Maxidex One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Vehicle One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Overall Study STARTED	42	41	41	40
Overall Study Treated	41	41	40	40
Overall Study COMPLETED	41	41	40	38
Overall Study NOT COMPLETED	1	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AL-78843 One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Maxidex One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Vehicle One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	0	0	1
Overall Study Randomization error (prior to treatment)	1	1	0

Baseline Characteristics

Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AL-78843 n=41 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	AL-53817 n=41 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Maxidex n=40 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Vehicle n=40 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Total n=162 Participants Total of all reporting groups
Age, Continuous	42.8 years STANDARD_DEVIATION 13.4 • n=5 Participants	46.4 years STANDARD_DEVIATION 13.3 • n=7 Participants	40.9 years STANDARD_DEVIATION 13.1 • n=5 Participants	46.0 years STANDARD_DEVIATION 12.6 • n=4 Participants	44.0 years STANDARD_DEVIATION 13.2 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	24 Participants n=4 Participants	88 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	74 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Population: This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.

Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	AL-78843 n=41 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	AL-53817 n=41 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Maxidex n=40 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)	Vehicle n=38 Participants One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7	-2.8 hours x units on a scale Standard Error 0.68	-4.7 hours x units on a scale Standard Error 0.68	-8.1 hours x units on a scale Standard Error 0.69	-4.5 hours x units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Population: This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.

Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\].