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

Phase 2

Completed

• Conditions: Long Term Follow up Dry Eye Disease
• Interventions: Drug: OC-01 Mid Dose, 0.6 mg/mL; Drug: Placebo (vehicle) nasal spray; Drug: OC-01 Low Dose, 0.12 mg/mL; Drug: OC-01 High Dose, 1.2 mg/mL

• Registration Number: NCT03920215
• Lead Sponsor: Oyster Point Pharma, Inc.

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.

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-18
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Disposition First Submitted: 2021-01-26
• Status Verified: 2021-09
• Results First Submitted: 2021-09-10
• Results First Submitted QC: 2021-10-21
• Disposition First Submitted QC: 2021-10-21
• Results First Posted: 2021-11-22
• Disposition First Posted: 2021-11-22
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OC-01 Mid Dose, 0.6 mg/mL	OC-01 Mid Dose, 0.6 mg/mL	OC-01 (varenicline) nasal spray, 0.60 mg/mL
Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray	Placebo (vehicle) nasal spray
OC-01 Low Dose, 0.12 mg/mL	OC-01 Low Dose, 0.12 mg/mL	OC-01 (varenicline) nasal spray, 0.12 mg/mL
OC-01 High Dose, 1.2 mg/mL	OC-01 High Dose, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL

Primary Outcome Measures

Name	Time	Method
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 Left 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	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 Left Nostril/Abnormal at 12 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 Right Nostril/Abnormal at 6 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)	Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations

Trial Locations

Locations (3)

Newport Beach; 🇺🇸 Newport Beach, California, United States

Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Andover; 🇺🇸 Andover, Massachusetts, United States