Long Term Follow up Dry Eye Disease Clinical Trial
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
Verified date | September 2021 |
Source | Oyster Point Pharma, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 101 |
Est. completion date | September 20, 2019 |
Est. primary completion date | September 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 1. Have been enrolled in the OPP-002 study 2. Have received at least one dose of the study drug/placebo in OPP-002 study 3. Completed the OPP-002 study to Visit 5 4. Have provided verbal and written informed consent Exclusion Criteria: 1. Have discontinued prior to Visit 5 in the OPP-002 study. |
Country | Name | City | State |
---|---|---|---|
United States | Andover | Andover | Massachusetts |
United States | Indianapolis | Indianapolis | Indiana |
United States | Newport Beach | Newport Beach | California |
Lead Sponsor | Collaborator |
---|---|
Oyster Point Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) |