Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis (NCT NCT04050865)

Last Updated: 2021-10-07

Results Overview

Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

96 participants

Primary outcome timeframe

3 minutes

Results posted on

2021-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	OTX-DP, 0.4 mg OTX-DP, 0.4 mg	Placebo Placebo Vehicle
Overall Study STARTED	48	48
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	OTX-DP, 0.4 mg OTX-DP, 0.4 mg	Placebo Placebo Vehicle
Overall Study Adverse Event	1	0
Overall Study no insert	1	0
Overall Study Only 1 insert	2	3
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OTX-DP n=48 Participants OTX-DP	Placebo n=48 Participants Placebo Vehicle	Total n=96 Participants Total of all reporting groups
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 12.45 • n=5 Participants	46.0 years STANDARD_DEVIATION 12.92 • n=7 Participants	44.9 years STANDARD_DEVIATION 12.67 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	48 participants n=7 Participants	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes

Population: ITT Population with Multiple Imputation (MCMC) Subject Level Imputation

Outcome measures

Outcome measures
Measure	OTX-DP n=48 Participants OTX-DP	Placebo n=48 Participants Placebo Vehicle
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)	1.80 units on a scale Interval 1.51 to 2.08	2.69 units on a scale Interval 2.4 to 2.98

PRIMARY outcome

Timeframe: 5 minutes

Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

Outcome measures

Outcome measures
Measure	OTX-DP n=48 Participants OTX-DP	Placebo n=48 Participants Placebo Vehicle
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)	1.73 units on a scale Interval 1.45 to 2.0	2.72 units on a scale Interval 2.44 to 3.01

PRIMARY outcome

Timeframe: 7 minutes

Outcome measures

Outcome measures
Measure	OTX-DP n=48 Participants OTX-DP	Placebo n=48 Participants Placebo Vehicle
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)	1.72 units on a scale Interval 1.43 to 2.0	2.71 units on a scale Interval 2.43 to 2.99

Adverse Events

OTX-DP

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OTX-DP n=48 participants at risk OTX-DP	Placebo n=48 participants at risk Placebo Vehicle
Eye disorders Treatment Emergent Adverse Events	33.3% 16/48 • 30 Days	29.2% 14/48 • 30 Days

Additional Information

Clinical Project Manager

Ocular Therapeutix

Phone: 781-357-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place