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Completed

NCT Number: NCT03920215

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

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).

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Key information

Conditions

Long Term Follow up Dry Eye Disease

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Newport Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Have discontinued prior to Visit 5 in the OPP-002 study.

Treatment and study plan

OC-01 Low Dose, 0.12 mg/mL

Drug

OC-01 (varenicline) nasal spray

Other names: OC-01 (varenicline) nasal spray, 0.12 mg/ml

OC-01 Mid Dose, 0.6 mg/mL

Drug

OC-01 (varenicline) nasal spray

OC-01 High Dose, 1.2 mg/mL

Drug

OC-01 (varenicline) nasal spray

Other names: OC-01 Mid Dose, 1.2 mg/mL

Placebo (vehicle) nasal spray

Drug

Placebo (vehicle) nasal spray

Primary outcomes

  1. 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 Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations

  2. 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 Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations

  3. 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 Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations

  4. 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)

    Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations

Sponsors and collaborators

Lead sponsor

Oyster Point Pharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.