Phase 3
Completed 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
Source: ClinicalTrials.gov NCT03920215 ↗
Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations — 0; 0; 0; 0 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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. Informational only — not medical advice.