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

Phase 3CompletedNCT03920215

Oyster Point Pharma, Inc.101 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Long Term Follow up Dry Eye Disease

Interventions

OC-01 Low Dose, 0.12 mg/mLDRUG

OC-01 (varenicline) nasal spray

OC-01 Mid Dose, 0.6 mg/mLDRUG

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mLDRUG

OC-01 (varenicline) nasal spray

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (3)

Newport Beach

Newport Beach, California, United States

Indianapolis

Indianapolis, Indiana, United States

Andover

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

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

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)

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

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)

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

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)

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

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)

Data from ClinicalTrials.gov

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