Trial Outcomes & Findings for Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study) (NCT NCT03633461)

Last Updated: 2022-03-09

Results Overview

The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-02. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

28 days [Visit 1 (baseline) and Visit 5 (28 Days)]

Results posted on

2022-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml	Placebo Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Overall Study STARTED	34	19
Overall Study COMPLETED	34	18
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml	Placebo Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml n=34 Participants OC-02 (simpinicline) nasal spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml	Placebo n=19 Participants Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray	Total n=53 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 13.5 • n=5 Participants	64.7 years STANDARD_DEVIATION 11.5 • n=7 Participants	63.7 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	15 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	19 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	31 Participants n=5 Participants	18 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	19 participants n=7 Participants	53 participants n=5 Participants
Schirmer's Test	6.3 mm STANDARD_DEVIATION 3.1 • n=5 Participants	5.1 mm STANDARD_DEVIATION 3.1 • n=7 Participants	5.9 mm STANDARD_DEVIATION 3.1 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days [Visit 1 (baseline) and Visit 5 (28 Days)]

Population: Subjects in the ITT population

Outcome measures

Outcome measures
Measure	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml n=34 Participants OC-02 (simpinicline) nasal spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml	Placebo n=18 Participants Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Mean Change in Schirmer's Test From Baseline to 28 Days	10.5 mm Interval 7.4 to 13.5	5.7 mm Interval 1.4 to 9.9

Adverse Events

OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jeffery Nau

Oyster Point Pharma, Inc.

Phone: 609-382-9035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml n=34 participants at risk OC-02 (simpinicline) nasal spray, 11.1 mg/ml OC-02 (simpinicline) nasal spray: OC-02 (simpinicline) nasal spray, 11.1 mg/ml	Placebo n=19 participants at risk Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Eye disorders Visual acuity reduced	8.8% 3/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Eye disorders Vision blurred	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	10.5% 2/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Eye disorders Eye irritation	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Sneezing	64.7% 22/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	10.5% 2/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Throat irritation	20.6% 7/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Rhinorrhea	5.9% 2/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Nasal discomfort	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Rinalgia	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Nasal inflamation	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Nasal dryness	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
General disorders Instillation site irritation	11.8% 4/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
General disorders Instillation site paresthesia	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Gastrointestinal disorders Aphtous ulcer	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Gastrointestinal disorders Dry mouth	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Infections and infestations Infection	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Infections and infestations Nasopharyngitis	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Injury, poisoning and procedural complications Joint injury	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Nervous system disorders Headache	2.9% 1/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	0.00% 0/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Cough	29.4% 10/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	5.3% 1/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Respiratory, thoracic and mediastinal disorders Dysaesthesia pharynx	8.8% 3/34 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)	47.4% 9/19 • Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)