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

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

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 Overview

• Status: Completed
• Conditions: Long Term Follow up Dry Eye Disease
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Newport Beach
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Indianapolis
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Oyster Point Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: OPP-002-01EXT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No