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Cholinergic Agonist

Nasal Spray Study in Sjogren's Dry Eye Disease

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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Mean Change in Best Corrected Visual Acuity
Mean Change in Dry Mouth Scale
Mean Change in Nose Dryness Scale

Side effects data

From 2023 Phase 4 trial • 39 Patients • NCT05700422
56%
Sneezing
100%
80%
60%
40%
20%
0%
Study treatment Arm
OC-01 (Varenicline Solution) 0.03 mg Nasal Spray

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,726,673 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
1,969 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
~15 spots leftby Dec 2025
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