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Nicotinic Acetylcholine Receptor Agonist

OC-01 (varenicline) nasal spray, 1.2 mg/mL for Neurotrophic Keratopathy

Phase 2
Waitlist Available
Research Sponsored by Oyster Point Pharma, Inc.
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 8 weeks
Awards & highlights

Study Summary

This trialtests if a nasal spray can help people with eye damage caused by nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks 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 from baseline in corneal fluorescein staining
Secondary outcome measures
Mean change from baseline in visual acuity at Week 8

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OC-01 (varenicline) nasal spray, 1.2 mg/mLActive Control1 Intervention
OC-01 (varenicline) nasal spray, 1.2 mg/mL
Group II: Placebo (vehicle control) nasal sprayPlacebo Group1 Intervention
Placebo (vehicle control) nasal spray

Find a Location

Who is running the clinical trial?

Oyster Point Pharma, Inc.Lead Sponsor
14 Previous Clinical Trials
1,920 Total Patients Enrolled

Frequently Asked Questions

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

Are there any historical precedents for the clinical testing of OC-01 (varenicline) nasal spray, 1.2 mg/mL?

"Currently, 26 trials involving OC-01 (varenicline) nasal spray, 1.2 mg/mL are ongoing with 4 of those studies in their final phase. The primary location for these tests is Charleston, South carolina but there are 69 other sites across the country running trial programs as well."

Answered by AI

Are there currently any available slots for interested participants in this examination?

"According to clinicaltrials.gov, this particular research endeavor is not currently recruiting patients; it was initially posted on June 17th 2021 and last modified on November 15th 2022. However, 28 other trials are presently accepting participants at this time."

Answered by AI

What is the current participant count for this clinical investigation?

"Unfortunately, the recruitment process for this trial has concluded. It was first posted on June 17th 2021 and subsequently edited on November 15th 2022. For those looking to participate in study trials, there are currently two clinical studies recruiting participants with neurotrophic keratopathy and 26 involving OC-01 (varenicline) nasal spray, 1.2 mg/mL that have open recruitment periods."

Answered by AI

In which geographical areas is this research endeavor being conducted?

"Currently, 32 sites are enlisting participants for the trial. These locations range from Aurora to Los Angeles and Dothan - selecting a site close by could help reduce travel complications if you choose to join in on this study."

Answered by AI

What is the aim of this experimental endeavor?

"This 8-week long trial will primarily measure changes in corneal fluorescein staining. In addition, the secondary endpoints of this research include evaluating visual acuity at week 8 (Secondary Endpoint #1), calculating the percentage of subjects that progress to Stage 2 Persistent Epithelial Defect (PED) NK by Week 8 (Secondary Endpoint #2), and gauging improvements in corneal sensitivity at week 8 (Secondary Endpoint #3)."

Answered by AI

To what extent can potential hazards be expected with the administration of OC-01 (varenicline) nasal spray, 1.2 mg/mL?

"Due to limited data demonstrating efficacy, the safety of OC-01 (varenicline) nasal spray, 1.2 mg/mL was estimated as a 2 on our team's rating scale."

Answered by AI
~29 spots leftby Apr 2025