Trial Outcomes & Findings for Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study) (NCT NCT03452397)

Last Updated: 2021-12-14

Results Overview

The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

Day 1 (Pre to Post-Treatment Change)

Results posted on

2021-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) 0.2% hemigalactarate (0.11% free base) 0.2% OC-02 Mid Dose (1.1 mg/mL)	1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL) 1% hemigalactarate (0.11% free base) 1% OC-02 Mid Dose (5.5 mg/mL)	2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL) 2% hemigalactarate (0.11% free base) 2% OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Overall Study STARTED	41	41	41	42
Overall Study COMPLETED	40	41	39	41
Overall Study NOT COMPLETED	1	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) 0.2% hemigalactarate (0.11% free base) 0.2% OC-02 Mid Dose (1.1 mg/mL)	2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL) 2% hemigalactarate (0.11% free base) 2% OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Overall Study Adverse Event	1	0	0
Overall Study Administrative reason	0	1	1
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n=41 Participants 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n=41 Participants 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n=41 Participants 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray n=42 Participants Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray	Total n=165 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 11.80 • n=5 Participants	64.0 years STANDARD_DEVIATION 11.15 • n=7 Participants	62.7 years STANDARD_DEVIATION 9.30 • n=5 Participants	64.4 years STANDARD_DEVIATION 11.76 • n=4 Participants	63.9 years STANDARD_DEVIATION 10.97 • n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	34 Participants n=4 Participants	118 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	47 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	41 Participants n=5 Participants	40 Participants n=7 Participants	41 Participants n=5 Participants	39 Participants n=4 Participants	161 Participants n=21 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	37 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	39 Participants n=4 Participants	150 Participants n=21 Participants
Race/Ethnicity, Customized Multiple races	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	41 participants n=5 Participants	41 participants n=7 Participants	41 participants n=5 Participants	42 participants n=4 Participants	165 participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 (Pre to Post-Treatment Change)

Population: Subjects in the ITT population

Outcome measures

Outcome measures
Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n=41 Participants 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n=41 Participants 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n=41 Participants 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray n=42 Participants Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Schirmer's Test Score at Day 1	9.0 mm Interval 6.3 to 11.6	17.5 mm Interval 14.8 to 20.2	19.6 mm Interval 16.9 to 22.3	3.0 mm Interval 0.3 to 5.6

PRIMARY outcome

Timeframe: Day 15 (Pre to Post-Treatment Change)

Population: Subjects in the ITT Population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics

Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n=37 Participants 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n=41 Participants 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n=38 Participants 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray n=41 Participants Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Eye Dryness Score at Visit 2	-9.4 mm Interval -15.4 to -3.5	-17.4 mm Interval -23.1 to -11.7	-20.7 mm Interval -26.7 to -14.7	-6.5 mm Interval -12.1 to -0.8

Adverse Events

0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo (Vehicle) Nasal Spray

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n=41 participants at risk 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n=41 participants at risk 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n=41 participants at risk 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray n=42 participants at risk Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Metabolism and nutrition disorders failure to thrive	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.

Other adverse events

Additional Information

Jeffrey 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	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n=41 participants at risk 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n=41 participants at risk 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n=41 participants at risk 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Placebo (Vehicle) Nasal Spray n=42 participants at risk Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray
Eye disorders Eye pruritus	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Eye disorders Keratits	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Respiratory, thoracic and mediastinal disorders Cough	19.5% 8/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	24.4% 10/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	36.6% 15/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Respiratory, thoracic and mediastinal disorders Throat irritation	14.6% 6/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	24.4% 10/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	24.4% 10/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Respiratory, thoracic and mediastinal disorders Sneezing	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	9.8% 4/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
General disorders Instillation site irritation	7.3% 3/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	9.8% 4/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	14.6% 6/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Infections and infestations Pharyngitis streptococcal	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Infections and infestations Upper respiratory tract infection	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Nervous system disorders Headache	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Nervous system disorders Paraesthesia	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Gastrointestinal disorders Gastrooesphageal reflux disease	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	2.4% 1/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Metabolism and nutrition disorders Failure to thrive	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Psychiatric disorders Acute stress disorder	2.4% 1/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.
Infections and infestations Nasopharyngitis	4.9% 2/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	7.3% 3/41 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.	0.00% 0/42 • Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.