A Phase 3 interventional study of AGN-229666 in Conjunctivitis, Allergic, sponsored by Allergan. Completed at 1 site in Japan. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2016-03-14.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of AGN-229666 for the treatment of seasonal or perennial allergic conjunctivitis.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 140 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
Drug: AGN-229666
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
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.
Time frame: Baseline, Day 70
| Milestone | AGN-229666 |
|---|---|
| Started | 140 |
| Completed | 89 |
| Not completed | 51 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Adverse event | 48 |
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.
| Scores on a Scale | AGN-229666 |
|---|---|
| Baseline | 4.4 ± 0.49 |
| Change from Baseline at Day 70 (N=110) | -3.4 ± 1.51 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AGN-229666 | — | 0/140 (0%) | 96/140 (68.6%) |
| Event | AGN-229666 |
|---|---|
| Conjunctival HyperaemiaEye disorders | 48/140 |
| Eye PruritusEye disorders | 28/140 |
| SomnolenceNervous system disorders | 26/140 |
| Eye DischargeEye disorders | 14/140 |
| Instillation Site IrritationGeneral disorders | 12/140 |
| Ciliary HyperaemiaEye disorders | 11/140 |
| Eyelid OedemaEye disorders | 9/140 |
| BlepharitisEye disorders | 8/140 |
| ConjunctivitisEye disorders | 8/140 |
| Conjunctival OedemaEye disorders | 7/140 |
| Age, Customized(Participants) | AGN-229666 |
|---|---|
| ≥ 10 to < 20 years | 38 |
| ≥ 20 to < 40 years | 44 |
| ≥ 40 years | 58 |
| Sex: Female, Male(Participants) | AGN-229666 |
|---|---|
| Female | 82 |
| Male | 58 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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