Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Long Term Follow up Dry Eye Disease

Intervention / Treatment
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* Drug: OC-01 Low Dose, 0.12 mg/mL
* Drug: OC-01 Mid Dose, 0.6 mg/mL
* Drug: OC-01 High Dose, 1.2 mg/mL
* Drug: Placebo (vehicle) nasal spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OC-01 Low Dose, 0.12 mg/mL<br>OC-01 (varenicline) nasal spray, 0.12 mg/mL | Drug: OC-01 Low Dose, 0.12 mg/mL<br>* OC-01 (varenicline) nasal spray<br>* Other names: OC-01 (varenicline) nasal spray, 0.12 mg/ml;|
| Active Comparator: OC-01 Mid Dose, 0.6 mg/mL<br>OC-01 (varenicline) nasal spray, 0.60 mg/mL | Drug: OC-01 Mid Dose, 0.6 mg/mL<br>* OC-01 (varenicline) nasal spray<br>|
| Active Comparator: OC-01 High Dose, 1.2 mg/mL<br>OC-01 (varenicline) nasal spray, 1.2 mg/mL | Drug: OC-01 High Dose, 1.2 mg/mL<br>* OC-01 (varenicline) nasal spray<br>* Other names: OC-01 Mid Dose, 1.2 mg/mL;|
| Placebo Comparator: Placebo (vehicle) nasal spray<br>Placebo (vehicle) nasal spray | Drug: Placebo (vehicle) nasal spray<br>* Placebo (vehicle) nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |