NCT03920215

Brief Summary

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 22, 2021

Completed
Last Updated

November 1, 2023

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

April 9, 2019

Results QC Date

September 10, 2021

Last Update Submit

October 30, 2023

Conditions

Long Term Follow up Dry Eye Disease

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations

    Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations

    6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)

  • Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations

    Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations

    6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)

  • Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations

    Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations

    12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)

  • Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations

    Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations

    12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)

Study Arms (4)

OC-01 Low Dose, 0.12 mg/mL

ACTIVE COMPARATOR

OC-01 (varenicline) nasal spray, 0.12 mg/mL

Drug: OC-01 Low Dose, 0.12 mg/mL

OC-01 Mid Dose, 0.6 mg/mL

ACTIVE COMPARATOR

OC-01 (varenicline) nasal spray, 0.60 mg/mL

Drug: OC-01 Mid Dose, 0.6 mg/mL

OC-01 High Dose, 1.2 mg/mL

ACTIVE COMPARATOR

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

Drug: OC-01 High Dose, 1.2 mg/mL

Placebo (vehicle) nasal spray

PLACEBO COMPARATOR

Placebo (vehicle) nasal spray

Drug: Placebo (vehicle) nasal spray

Interventions

OC-01 Low Dose, 0.12 mg/mLDRUG

OC-01 (varenicline) nasal spray

Also known as: OC-01 (varenicline) nasal spray, 0.12 mg/ml
OC-01 Low Dose, 0.12 mg/mL
OC-01 Mid Dose, 0.6 mg/mLDRUG

OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mL
OC-01 High Dose, 1.2 mg/mLDRUG

OC-01 (varenicline) nasal spray

Also known as: OC-01 Mid Dose, 1.2 mg/mL
OC-01 High Dose, 1.2 mg/mL
Placebo (vehicle) nasal sprayDRUG

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been enrolled in the OPP-002 study
  • Have received at least one dose of the study drug/placebo in OPP-002 study
  • Completed the OPP-002 study to Visit 5
  • Have provided verbal and written informed consent

You may not qualify if:

  • \. Have discontinued prior to Visit 5 in the OPP-002 study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Newport Beach

Newport Beach, California, 92663, United States

Location

Indianapolis

Indianapolis, Indiana, 46290, United States

Location

Andover

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Interventions

VareniclineNasal Sprays

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Jeffrey Nau
Organization
Oyster Point Pharma, Inc.
jnau@oysterpointrx.com
609-382-9035

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 18, 2019

Study Start

August 15, 2018

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

November 1, 2023

Results First Posted

November 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)