Trial Outcomes & Findings for AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis (NCT NCT02082262)
NCT ID: NCT02082262
Last Updated: 2016-03-14
Results Overview
Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
COMPLETED
PHASE3
140 participants
Baseline, Day 70
2016-03-14
Participant Flow
Participant milestones
| Measure |
AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
|
|---|---|
|
Overall Study
STARTED
|
140
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
AGN-229666
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Adverse Event
|
48
|
Baseline Characteristics
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
AGN-229666
n=140 Participants
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
|
|---|---|
|
Age, Customized
≥ 10 to < 20 years
|
38 Participants
n=39 Participants
|
|
Age, Customized
≥ 20 to < 40 years
|
44 Participants
n=39 Participants
|
|
Age, Customized
≥ 40 years
|
58 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 70Population: Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score
Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
AGN-229666
n=140 Participants
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
|
|---|---|
|
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Baseline
|
4.4 Scores on a Scale
Standard Deviation 0.49
|
|
Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Change from Baseline at Day 70 (N=110)
|
-3.4 Scores on a Scale
Standard Deviation 1.51
|
Adverse Events
AGN-229666
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGN-229666
n=140 participants at risk
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
|
|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
34.3%
48/140
|
|
Eye disorders
Eye Pruritus
|
20.0%
28/140
|
|
Nervous system disorders
Somnolence
|
18.6%
26/140
|
|
Eye disorders
Eye Discharge
|
10.0%
14/140
|
|
General disorders
Instillation Site Irritation
|
8.6%
12/140
|
|
Eye disorders
Ciliary Hyperaemia
|
7.9%
11/140
|
|
Eye disorders
Eyelid Oedema
|
6.4%
9/140
|
|
Eye disorders
Blepharitis
|
5.7%
8/140
|
|
Eye disorders
Conjunctivitis
|
5.7%
8/140
|
|
Eye disorders
Conjunctival Oedema
|
5.0%
7/140
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
7/140
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER