OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02445326

Enrollment

Registered

2015-05-15

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Allergic Conjunctivitis

Brief summary

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

Interventions

DRUGDexamethasone

OTHERPlacebo Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion criteria

* History of refractive surgery (including LASIK procedures) * History of retinal detachment, diabetic retinopathy, or active retinal disease * Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * Use any of the disallowed medications during the period indicated * History of IOP increase as a result of steroid treatment

Design outcomes

Primary

Measure	Time frame	Description
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6	3 minutes	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None
Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6	7 minutes	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

Participant flow

Participants by arm

Arm	Count
OTX-DP OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use	35
Placebo Vehicle PV (placebo drug delivery vehicle)	38
Total	73

Baseline characteristics

Characteristic	OTX-DP	Placebo Vehicle	Total
Age, Continuous	38.2 years	36.3 years	37 years
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	6 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants	31 Participants	62 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	2 Participants
Iris Color Blue	4 Participants	1 Participants	5 Participants
Iris Color Brown	26 Participants	32 Participants	58 Participants
Iris Color Green	4 Participants	5 Participants	9 Participants
Iris Color Hazel	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	13 Participants	11 Participants	24 Participants
Race (NIH/OMB) Black or African American	10 Participants	9 Participants	19 Participants
Race (NIH/OMB) More than one race	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	4 Participants	6 Participants
Race (NIH/OMB) White	10 Participants	12 Participants	22 Participants
Sex: Female, Male Female	17 Participants	14 Participants	31 Participants
Sex: Female, Male Male	18 Participants	24 Participants	42 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 38
other Total, other adverse events	3 / 35	4 / 38
serious Total, serious adverse events	0 / 35	0 / 38