Trial Outcomes & Findings for Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model (NCT NCT01479374)
NCT ID: NCT01479374
Last Updated: 2013-06-04
Results Overview
A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
COMPLETED
PHASE3
397 participants
3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
2013-06-04
Participant Flow
Patients were recruited from three US study centers.
Of the 397 enrolled, 195 subjects did not qualify for treatment and were exited without exposure to product. Participant flow and baseline characteristics are presented for the 202 subjects qualifying for treatment and randomized 1:1:1 to receive AL-4943A, Vehicle, or Pataday.
Participant milestones
| Measure |
AL-4943A
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
68
|
|
Overall Study
COMPLETED
|
63
|
60
|
63
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
5
|
Reasons for withdrawal
| Measure |
AL-4943A
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Decision Unrelated to Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
4
|
5
|
Baseline Characteristics
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
Baseline characteristics by cohort
| Measure |
AL-4943A
n=66 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=68 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=68 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 64 years
|
64 participants
n=5 Participants
|
66 participants
n=7 Participants
|
66 participants
n=5 Participants
|
196 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
68 participants
n=7 Participants
|
68 participants
n=5 Participants
|
202 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=63 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=60 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=63 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Ocular Itching at Onset of Action
3 min post-CAC
|
0.4 Units on a scale
Standard Deviation 0.7
|
1.9 Units on a scale
Standard Deviation 1.1
|
0.4 Units on a scale
Standard Deviation 0.6
|
|
Mean Ocular Itching at Onset of Action
5 min post-CAC
|
0.6 Units on a scale
Standard Deviation 0.8
|
2.1 Units on a scale
Standard Deviation 1.1
|
0.7 Units on a scale
Standard Deviation 0.7
|
|
Mean Ocular Itching at Onset of Action
7 min post-CAC
|
0.5 Units on a scale
Standard Deviation 0.7
|
2.0 Units on a scale
Standard Deviation 1.1
|
0.7 Units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=65 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=65 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=65 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Ocular Itching at 16 Hours Duration of Action
3 min post-CAC
|
0.7 Units on a scale
Standard Deviation 0.7
|
2.2 Units on a scale
Standard Deviation 0.9
|
0.9 Units on a scale
Standard Deviation 0.8
|
|
Mean Ocular Itching at 16 Hours Duration of Action
5 min post-CAC
|
0.8 Units on a scale
Standard Deviation 0.8
|
2.3 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 1.0
|
|
Mean Ocular Itching at 16 Hours Duration of Action
7 min post-CAC
|
0.8 Units on a scale
Standard Deviation 0.9
|
2.1 Units on a scale
Standard Deviation 0.9
|
1.0 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=63 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=60 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=63 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Conjunctival Redness at Onset of Action
7 min post-CAC
|
0.8 Units on a scale
Standard Deviation 0.7
|
2.1 Units on a scale
Standard Deviation 0.7
|
1.3 Units on a scale
Standard Deviation 0.8
|
|
Mean Conjunctival Redness at Onset of Action
15 min post-CAC
|
1.1 Units on a scale
Standard Deviation 0.9
|
2.3 Units on a scale
Standard Deviation 0.6
|
1.9 Units on a scale
Standard Deviation 0.8
|
|
Mean Conjunctival Redness at Onset of Action
20 min post-CAC
|
1.1 Units on a scale
Standard Deviation 0.8
|
2.3 Units on a scale
Standard Deviation 0.7
|
1.9 Units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=65 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=65 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=65 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Conjunctival Redness at 16 Hours Duration of Action
7 min post-CAC
|
1.3 Units on a scale
Standard Deviation 0.8
|
1.8 Units on a scale
Standard Deviation 0.8
|
1.6 Units on a scale
Standard Deviation 0.7
|
|
Mean Conjunctival Redness at 16 Hours Duration of Action
15 min post-CAC
|
1.5 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.7
|
|
Mean Conjunctival Redness at 16 Hours Duration of Action
20 min post-CAC
|
1.5 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.9
|
1.9 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=66 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=68 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=66 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Total Redness at 24 Hours Duration of Action
7 min post-CAC
|
4.1 Units on a scale
Standard Deviation 2.6
|
6.1 Units on a scale
Standard Deviation 2.3
|
5.4 Units on a scale
Standard Deviation 2.4
|
|
Mean Total Redness at 24 Hours Duration of Action
15 min post-CAC
|
5.0 Units on a scale
Standard Deviation 2.9
|
6.7 Units on a scale
Standard Deviation 2.3
|
6.2 Units on a scale
Standard Deviation 2.3
|
|
Mean Total Redness at 24 Hours Duration of Action
20 min post-CAC
|
5.4 Units on a scale
Standard Deviation 2.9
|
6.6 Units on a scale
Standard Deviation 2.6
|
6.3 Units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=66 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=68 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=66 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Ocular Itching at 24 Hours Duration of Action
3 min post-CAC
|
0.9 Units on a scale
Standard Deviation 0.8
|
2.5 Units on a scale
Standard Deviation 0.8
|
1.4 Units on a scale
Standard Deviation 0.8
|
|
Mean Ocular Itching at 24 Hours Duration of Action
5 min post-CAC
|
1.1 Units on a scale
Standard Deviation 0.9
|
2.6 Units on a scale
Standard Deviation 0.8
|
1.5 Units on a scale
Standard Deviation 0.9
|
|
Mean Ocular Itching at 24 Hours Duration of Action
7 min post-CAC
|
1.1 Units on a scale
Standard Deviation 0.9
|
2.5 Units on a scale
Standard Deviation 0.9
|
1.5 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatmentPopulation: Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.
A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Outcome measures
| Measure |
AL-4943A
n=66 Participants
AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
|
Vehicle
n=68 Participants
AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
|
Pataday
n=66 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
|
|---|---|---|---|
|
Mean Conjunctival Redness at 24 Hours Duration of Action
7 min post-CAC
|
1.5 Units on a scale
Standard Deviation 0.8
|
2.1 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.8
|
|
Mean Conjunctival Redness at 24 Hours Duration of Action
15 min post-CAC
|
1.8 Units on a scale
Standard Deviation 0.9
|
2.3 Units on a scale
Standard Deviation 0.7
|
2.1 Units on a scale
Standard Deviation 0.7
|
|
Mean Conjunctival Redness at 24 Hours Duration of Action
20 min post-CAC
|
1.8 Units on a scale
Standard Deviation 0.9
|
2.3 Units on a scale
Standard Deviation 0.9
|
2.1 Units on a scale
Standard Deviation 0.7
|
Adverse Events
AL-4943A
Vehicle
Pataday
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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