Trial Outcomes & Findings for Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (NCT NCT03688802)

NCT ID: NCT03688802

Last Updated: 2021-12-29

Results Overview

Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Baseline (pre-treatment), 1 day (post treatment)

Results posted on

2021-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray	Placebo (Vehicle Control) Nasal Spray Placebo (vehicle control) nasal spray Placebo (vehicle control) nasal spray: Placebo
Overall Study STARTED	12	6
Overall Study COMPLETED	11	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OC-01, 1.2 mg/mL n=12 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=6 Participants Placebo (vehicle) nasal spray: Placebo	Total n=18 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 13.79 • n=5 Participants	63.3 years STANDARD_DEVIATION 13.46 • n=7 Participants	61.4 years STANDARD_DEVIATION 13.35 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=5 Participants	0 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	15 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants
Schirmer's Test Score	6.6 mm STANDARD_DEVIATION 4.42 • n=5 Participants	4.5 mm STANDARD_DEVIATION 3.89 • n=7 Participants	5.9 mm STANDARD_DEVIATION 4.25 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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.

Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=7 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=3 Participants Placebo: Placebo Vehicle ) nasal spray
Mean Change in Goblet Cell Area	-38.8 um Standard Deviation 30.20	-6.7 um Standard Deviation 1.94

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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.

Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=7 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=3 Participants Placebo: Placebo Vehicle ) nasal spray
Mean Change in Goblet Cell Perimeter	-7.7 um Standard Deviation 5.79	-1.8 um Standard Deviation 0.76

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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 Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=10 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=6 Participants Placebo: Placebo Vehicle ) nasal spray
Change in Meibomian Gland Area, Upper Lid	11.2 um Standard Deviation 118.6	-143.2 um Standard Deviation 154.8

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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.

Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=9 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=6 Participants Placebo: Placebo Vehicle ) nasal spray
Mean Change in Meibomian Gland Area, Lower Lid.	-29.9 um Standard Deviation 88.1	-12.4 um Standard Deviation 95.8

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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.

Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=10 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=6 Participants Placebo: Placebo Vehicle ) nasal spray
Mean Change in Meibomian Gland Perimeter, Upper Lid.	6.15 um Standard Deviation 16.6	-19.2 um Standard Deviation 22.8

PRIMARY outcome

Timeframe: Baseline (pre-treatment), 1 day (post treatment)

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.

Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.

Outcome measures

Outcome measures
Measure	OC-01, 1.2 mg/mL n=9 Participants OC-01: OC-01 (varenicline) nasal spray	Placebo n=6 Participants Placebo: Placebo Vehicle ) nasal spray
Mean Change in Meibomian Gland Perimeter, Lower Lid	-4 um Standard Deviation 10.9	4.2 um Standard Deviation 19.3

Adverse Events

OC-01, 1.2 mg/mL

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OC-01, 1.2 mg/mL n=12 participants at risk OC-01 (varenicline) nasal spray, 1.2 mg/mL	Placebo n=6 participants at risk Placebo (vehicle control) nasal spray
Eye disorders TEAE	0.00% 0/12 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).	0.00% 0/6 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).
Respiratory, thoracic and mediastinal disorders Sneezing	41.7% 5/12 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).	16.7% 1/6 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	16.7% 2/12 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).	0.00% 0/6 • Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).

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