A Phase 2 interventional study of Dexamethasone and Placebo Vehicle in Chronic Allergic Conjunctivitis, sponsored by Ocular Therapeutix, Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Ocular Therapeutix, Inc. · Phase 2, Interventional, and Treatment
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 68 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →Ocular Therapeutix, Inc. is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Drug: Dexamethasone
PV (placebo drug delivery vehicle)
Other: Placebo Vehicle
Ocular Itching
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
Time frame: 14 days post insertion
Conjunctival Redness
Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)
Time frame: 14 days post insertion
| Milestone | OTX-DP Treatment | Placebo Plug Delivery Vehicle |
|---|---|---|
| Started | 35 | 33 |
| Completed | 28 | 31 |
| Not completed | 7 | 2 |
Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
| units on a scale (0 -4) | OTX-DP Treatment | Placebo Plug Delivery Vehicle |
|---|---|---|
| 3 min (14 days post-insertion) | 1.80 ± 1.068 | 2.58 ± 0.823 |
| 5 min. (14 days post-insertion) | 1.72 ± 0.998 | 2.70 ± 0.865 |
| 7 min. (14 days post-insertion) | 1.65 ± 0.989 | 2.53 ± 0.880 |
Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)
| units on a scale (0 - 4) | OTX-DP Treatment | Placebo Plug Delivery Vehicle |
|---|---|---|
| 7 min. (14 days post-insertion) | 1.60 ± 0.753 | 2.11 ± 0.727 |
| 15 min. (14 days post-insertion) | 1.53 ± 0.753 | 2.23 ± 0.708 |
| 20 min. (14 days post-insertion) | 1.54 ± 0.739 | 2.21 ± 0.696 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OTX-DP Treatment | — | 1/31 (3.2%) | 1/31 (3.2%) |
| Placebo Plug Delivery Vehicle | — | 0/33 (0%) | 2/33 (6.1%) |
| Event | OTX-DP Treatment | Placebo Plug Delivery Vehicle |
|---|---|---|
| depressionPsychiatric disorders | 1/31 | 0/33 |
| Event | OTX-DP Treatment | Placebo Plug Delivery Vehicle |
|---|---|---|
| eye dischargeEye disorders | 1/31 | 2/33 |
| Age, Categorical(Participants) | OTX-DP Treatment | Placebo Plug Delivery Vehicle | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 30 | 64 |
| >=65 years | 1 | 3 | 4 |
| Sex: Female, Male(Participants) | OTX-DP Treatment | Placebo Plug Delivery Vehicle | Total |
|---|---|---|---|
| Female | 18 | 17 | 35 |
| Male | 17 | 16 | 33 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Ocular Therapeutix, Inc.