Clinical trial NCT03920215: Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Long Term Follow up Dry Eye Disease
Lead sponsor: Oyster Point Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 101
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
timeFrame: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
measure: Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
timeFrame: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
measure: Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
timeFrame: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
measure: Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
timeFrame: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Newport Beach
state: California
city: Indianapolis
country: United States
facility: Indianapolis
state: Indiana
city: Andover
country: United States
facility: Andover
state: Massachusetts
Study officials:
References: