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

Long Term Follow up Dry Eye Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920215
• Other study ID #: OPP-002-01EXT
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 15, 2018
• Est. completion date: September 20, 2019

Study information

• Verified date: September 2021
• Source: Oyster Point Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Long Term Follow up Dry Eye Disease

Intervention

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

Locations

Country	Name	City	State
United States	Andover	Andover	Massachusetts
United States	Indianapolis	Indianapolis	Indiana
United States	Newport Beach	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)