Back to resultsEvaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Primary Purpose
Long Term Follow up Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OC-01 Low Dose, 0.12 mg/mL
OC-01 Mid Dose, 0.6 mg/mL
OC-01 High Dose, 1.2 mg/mL
Placebo (vehicle) nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Long Term Follow up Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Have discontinued prior to Visit 5 in the OPP-002 study.
Sites / Locations
- Newport Beach
- Indianapolis
- Andover
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
OC-01 Low Dose, 0.12 mg/mL
OC-01 Mid Dose, 0.6 mg/mL
OC-01 High Dose, 1.2 mg/mL
Placebo (vehicle) nasal spray
Arm Description
OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 (varenicline) nasal spray, 0.60 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
Placebo (vehicle) nasal spray
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03920215
First Posted
April 9, 2019
Last Updated
October 21, 2021
Sponsor
Oyster Point Pharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03920215
Brief Title
Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Official Title
Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)-Long Term Safety Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oyster Point Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.
The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Term Follow up Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OC-01 Low Dose, 0.12 mg/mL
Arm Type
Active Comparator
Arm Description
OC-01 (varenicline) nasal spray, 0.12 mg/mL
Arm Title
OC-01 Mid Dose, 0.6 mg/mL
Arm Type
Active Comparator
Arm Description
OC-01 (varenicline) nasal spray, 0.60 mg/mL
Arm Title
OC-01 High Dose, 1.2 mg/mL
Arm Type
Active Comparator
Arm Description
OC-01 (varenicline) nasal spray, 1.2 mg/mL
Arm Title
Placebo (vehicle) nasal spray
Arm Type
Placebo Comparator
Arm Description
Placebo (vehicle) nasal spray
Intervention Type
Drug
Intervention Name(s)
OC-01 Low Dose, 0.12 mg/mL
Other Intervention Name(s)
OC-01 (varenicline) nasal spray, 0.12 mg/ml
Intervention Description
OC-01 (varenicline) nasal spray
Intervention Type
Drug
Intervention Name(s)
OC-01 Mid Dose, 0.6 mg/mL
Intervention Description
OC-01 (varenicline) nasal spray
Intervention Type
Drug
Intervention Name(s)
OC-01 High Dose, 1.2 mg/mL
Other Intervention Name(s)
OC-01 Mid Dose, 1.2 mg/mL
Intervention Description
OC-01 (varenicline) nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo (vehicle) nasal spray
Intervention Description
Placebo (vehicle) nasal spray
Primary Outcome Measure Information:
Title
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Description
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Time Frame
6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Title
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Description
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Time Frame
6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Title
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Description
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Time Frame
12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Title
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Description
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Time Frame
12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. Have discontinued prior to Visit 5 in the OPP-002 study.
Facility Information:
Facility Name
Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Andover
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
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