Trial Outcomes & Findings for Nasal Spray Study in Sjogren's Dry Eye Disease (NCT NCT05700422)

Last Updated: 2024-11-05

Results Overview

The National Eye Institute (NEI) scale is the method that will be used to measure corneal staining using fluorescein strips on a scale of 0-3. The scale is a density-based scoring from 0-3 with 0 indicating no staining and 3 indicating highest density of staining.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2024-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray every 12 hours
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal Spray Study in Sjogren's Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=39 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Cornea Staining	-1.78 units on a scale Interval -2.09 to -1.47

PRIMARY outcome

Timeframe: Baseline to Day 28

VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Eye Dryness Score as Measured by the Visual Analogue Scale (VAS)	-14.51 score on a scale Interval -25.6 to -3.41

PRIMARY outcome

Timeframe: Baseline to Day 28

The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining.

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Conjunctival Staining	-0.46 units on a scale Interval -0.91 to -0.01

SECONDARY outcome

Timeframe: Baseline to Day 28

LogMAR or Logarithm of the Minimum Angle of Resolution was the method used for measuring best correct visual acuity (BCVA). LogMAR is a scale from -0.2 to 1.6 where the letter size is described in LogMAR units such that LogMAR -0.2 is equivalent to 20/12 (best vision) and LogMAR 1.6 is equivalent to 20/800 (Worse vision). The letter size change in units of 0.1 LogMAR from one row to the next.

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Best Corrected Visual Acuity	0.01 logMAR Interval -0.04 to 0.05

SECONDARY outcome

Timeframe: Baseline to Day 28

VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Dry Mouth Scale	-9.58 units on a scale Interval -20.52 to 1.35

SECONDARY outcome

Timeframe: Baseline to Day 28

VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."

Outcome measures

Outcome measures
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=35 Participants Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Mean Change in Nose Dryness Scale	-0.44 units on a scale Interval -11.16 to 12.05

Adverse Events

OC-01 (Varenicline Solution) 0.03 mg Nasal Spray

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray n=39 participants at risk Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray
Respiratory, thoracic and mediastinal disorders Sneezing	56.4% 22/39 • Adverse Events were collected over the 1 month of each participants enrollment.

Additional Information

Ophthalmology Clinical Research

Scheie Eye Institute

Phone: 215-662-8038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place