Trial Outcomes & Findings for Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis (NCT NCT01743027)

NCT ID: NCT01743027

Last Updated: 2014-08-11

Results Overview

A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 902 participants
• Primary outcome timeframe: Day 14 (3, 5, and 7 minutes post-CAC)
• Results posted on: 2014-08-11

Participant Flow

Participants were recruited from 6 study centers located in the US.

Of the 902 enrolled, 557 participants discontinued prior to randomization due to screen failure (390), adverse event (12), lost to follow-up (26), protocol violation (2), withdrawal by patient (85), and other (42). This reporting group includes all randomized participants (345).

Participant milestones

Measure	AL-4943A AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Overall Study STARTED	98	99	99	49
Overall Study COMPLETED	93	94	90	48
Overall Study NOT COMPLETED	5	5	9	1

Reasons for withdrawal

Measure	AL-4943A AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Overall Study Adverse Event	2	0	0	0
Overall Study Lost to Follow-up	0	0	2	0
Overall Study Progressive Disease	1	4	3	0
Overall Study Protocol Violation	1	1	1	0
Overall Study Withdrawal by Subject	1	0	3	1

Baseline Characteristics

Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

Baseline characteristics by cohort

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Total n=345 Participants Total of all reporting groups
Age, Customized 18-64 Years	97 participants n=93 Participants	93 participants n=4 Participants	95 participants n=27 Participants	48 participants n=483 Participants	333 participants n=36 Participants
Age, Customized ≥65 - <75 Years	1 participants n=93 Participants	5 participants n=4 Participants	4 participants n=27 Participants	1 participants n=483 Participants	11 participants n=36 Participants
Age, Customized ≥75 - <85 Years	0 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants
Sex: Female, Male Female	61 Participants n=93 Participants	55 Participants n=4 Participants	56 Participants n=27 Participants	32 Participants n=483 Participants	204 Participants n=36 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	44 Participants n=4 Participants	43 Participants n=27 Participants	17 Participants n=483 Participants	141 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 14 (3, 5, and 7 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Ocular Itching at Onset of Action 3 minutes post-CAC	0.38 units on a scale Standard Error 0.069	0.47 units on a scale Standard Error 0.069	0.59 units on a scale Standard Error 0.070	1.91 units on a scale Standard Error 0.095
Mean Ocular Itching at Onset of Action 5 minutes post-CAC	0.53 units on a scale Standard Error 0.075	0.61 units on a scale Standard Error 0.075	0.79 units on a scale Standard Error 0.076	1.99 units on a scale Standard Error 0.103
Mean Ocular Itching at Onset of Action 7 minutes post-CAC	0.65 units on a scale Standard Error 0.081	0.61 units on a scale Standard Error 0.082	0.83 units on a scale Standard Error 0.083	1.82 units on a scale Standard Error 0.113

PRIMARY outcome

Timeframe: Day 1 (3, 5, and 7 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Ocular Itching at 24 Hours Duration of Action 3 minutes post-CAC	1.01 units on a scale Standard Error 0.093	1.33 units on a scale Standard Error 0.093	1.53 units on a scale Standard Error 0.093	2.30 units on a scale Standard Error 0.132
Mean Ocular Itching at 24 Hours Duration of Action 5 minutes post-CAC	1.22 units on a scale Standard Error 0.092	1.48 units on a scale Standard Error 0.092	1.70 units on a scale Standard Error 0.091	2.37 units on a scale Standard Error 0.130
Mean Ocular Itching at 24 Hours Duration of Action 7 minutes post-CAC	1.25 units on a scale Standard Error 0.097	1.41 units on a scale Standard Error 0.097	1.64 units on a scale Standard Error 0.096	2.14 units on a scale Standard Error 0.137

SECONDARY outcome

Timeframe: Day 14 (7, 15, and 20 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Conjunctival Redness at Onset of Action 7 minutes post-CAC	1.34 units on a scale Standard Error 0.082	1.62 units on a scale Standard Error 0.082	1.65 units on a scale Standard Error 0.083	1.96 units on a scale Standard Error 0.113
Mean Conjunctival Redness at Onset of Action 15 minutes post-CAC	1.65 units on a scale Standard Error 0.082	1.96 units on a scale Standard Error 0.082	1.97 units on a scale Standard Error 0.083	2.10 units on a scale Standard Error 0.112
Mean Conjunctival Redness at Onset of Action 20 minutes post-CAC	1.66 units on a scale Standard Error 0.082	1.97 units on a scale Standard Error 0.082	1.97 units on a scale Standard Error 0.083	2.15 units on a scale Standard Error 0.113

SECONDARY outcome

Timeframe: Day 1 (7, 15, and 20 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Conjunctival Redness at 24 Hours Duration of Action 7 minutes post-CAC	1.92 units on a scale Standard Error 0.074	2.01 units on a scale Standard Error 0.073	1.97 units on a scale Standard Error 0.073	2.09 units on a scale Standard Error 0.104
Mean Conjunctival Redness at 24 Hours Duration of Action 15 minutes post-CAC	2.04 units on a scale Standard Error 0.073	2.21 units on a scale Standard Error 0.073	2.10 units on a scale Standard Error 0.073	2.22 units on a scale Standard Error 0.104
Mean Conjunctival Redness at 24 Hours Duration of Action 20 minutes post-CAC	2.08 units on a scale Standard Error 0.078	2.19 units on a scale Standard Error 0.078	2.07 units on a scale Standard Error 0.077	2.23 units on a scale Standard Error 0.110

SECONDARY outcome

Timeframe: Day 14 (7, 15, and 20 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Total Redness at Onset of Action 7 minutes post-CAC	3.92 units on a scale Standard Error 0.239	4.73 units on a scale Standard Error 0.240	4.82 units on a scale Standard Error 0.243	5.93 units on a scale Standard Error 0.330
Mean Total Redness at Onset of Action 15 minutes post-CAC	4.80 units on a scale Standard Error 0.240	5.73 units on a scale Standard Error 0.240	5.85 units on a scale Standard Error 0.243	6.50 units on a scale Standard Error 0.330
Mean Total Redness at Onset of Action 20 minutes post-CAC	4.96 units on a scale Standard Error 0.244	5.88 units on a scale Standard Error 0.245	5.88 units on a scale Standard Error 0.248	6.67 units on a scale Standard Error 0.337

SECONDARY outcome

Timeframe: Day 1 (7, 15, and 20 minutes post-CAC)

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Mean Total Redness at 24 Hours Duration of Action 7 minutes post-CAC	5.39 units on a scale Standard Error 0.214	5.77 units on a scale Standard Error 0.213	5.66 units on a scale Standard Error 0.212	6.12 units on a scale Standard Error 0.302
Mean Total Redness at 24 Hours Duration of Action 15 minutes post-CAC	5.87 units on a scale Standard Error 0.216	6.42 units on a scale Standard Error 0.215	6.11 units on a scale Standard Error 0.215	6.49 units on a scale Standard Error 0.306
Mean Total Redness at 24 Hours Duration of Action 20 minutes post-CAC	6.00 units on a scale Standard Error 0.230	6.41 units on a scale Standard Error 0.228	6.02 units on a scale Standard Error 0.228	6.49 units on a scale Standard Error 0.325

SECONDARY outcome

Timeframe: Day 14

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.

A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Proportion of Ocular Itching Responders at Onset of Action	71.4 percentage of participants	73.7 percentage of participants	59.6 percentage of participants	10.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.

A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.

Outcome measures

Measure	AL-4943A n=98 Participants AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATADAY n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	PATANOL n=99 Participants Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14	Vehicle n=49 Participants AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
Proportion of Itch Responders at 24 Hours Duration of Action	40.8 percentage of participants	30.3 percentage of participants	26.3 percentage of participants	4.1 percentage of participants

Adverse Events

AL-4943A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATADAY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PATANOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Wheeler, Unit Head, Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER