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Cholinergic Agonist

OC-01 (varenicline solution) 0.03 mg nasal spray for Sjogren's Syndrome

Phase 4

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 28

Awards & highlights

Study Summary

This trial is studying how well a nasal spray can treat dry eye in people with Sjogren's Syndrome. Eligible patients must be 18+, and will have 3 study visits over 1 month. Participants self-administer the nasal spray twice daily at home.

Eligible Conditions

Sjogren's Syndrome
Dry Eye Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in conjunctival staining

Mean change in cornea staining

Mean change in eye dryness score as measured by the Visual Analogue Scale (VAS)

Secondary outcome measures

Incidence and severity of adverse events

Mean change in best corrected visual acuity

Mean change in dry mouth scale

+1 more

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Depression

21%

Agitation

21%

Headache

14%

Allergies

14%

Heartburn

14%

Cold

14%

Back Pain

Cellulitis

Sinusitis

Stomach Pain

Panic

Angina

Aggression

Palpitations

Rash

Confusion

Dizziness

Fatigue

Leg Spasms

Increased Blood Pressure

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Trial Design

1Treatment groups

Experimental Treatment

Group I: OC-01 (varenicline solution) 0.03 mg nasal sprayExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline Nasal Spray

2023

Completed Phase 4

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,049 Total Patients Enrolled

4 Trials studying Sjogren's Syndrome

12,375 Patients Enrolled for Sjogren's Syndrome

Oyster Point Pharma, Inc.Industry Sponsor

14 Previous Clinical Trials

1,994 Total Patients Enrolled

Media Library

Varenicline Nasal Spray (Cholinergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05700422 — Phase 4

Sjogren's Syndrome Research Study Groups: OC-01 (varenicline solution) 0.03 mg nasal spray

Sjogren's Syndrome Clinical Trial 2023: Varenicline Nasal Spray Highlights & Side Effects. Trial Name: NCT05700422 — Phase 4

Varenicline Nasal Spray (Cholinergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05700422 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking volunteers at the moment?

"According to clinicaltrials.gov, the present recruitment period for this medical trial has been ongoing since May 1st 2023 and was recently updated on May 10th 2023."

Answered by AI

Has the federal agency given its sanction to OC-01 (varenicline solution) 0.03 mg nasal spray?

"Our team at Power deemed the safety of OC-01 nasal spray to be a 3, owing to its Phase 4 status and subsequent approval."

Answered by AI

How many individuals is the study recruiting?

"Yes, the clinicaltrials.gov database confirms that this research is actively searching for participants as of May 10th 2023. The trial was first posted on May 1st and requires a total of 40 recruits from one designated centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nasal Spray Study in Sjogren's Dry Eye Disease

Giacomina Massaro-Giordano 2023. "Nasal Spray Study in Sjogren's Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05700422.