Phase 3
N=101
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
Bottom Line
View on ClinicalTrials.gov: NCT03920215 ↗Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Oyster Point Pharma, Inc.
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations |
0; 0; 1; 0 | — |
| PRIMARY Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations |
0; 0; 1; 0 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03920215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.