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COMPLETED Phase 2

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

NCT03920215 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG 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

Study Locations (3)

California

  • Newport Beach — Newport Beach

Indiana

  • Indianapolis — Indianapolis

Massachusetts

  • Andover — Andover

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2018-08-15
Est. Completion 2019-09-20
Phase Phase 2

Sponsor

Oyster Point Pharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03920215

The ClinicalTrials.gov registry entry for NCT03920215 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oyster Point Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Long Term Follow up Dry Eye Disease appearing as the primary indexed condition, and to 4 interventions — of which OC-01 Low Dose, 0.12 mg/mL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03920215 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Indiana, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03920215 about?

NCT03920215 is a clinical study titled "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).

What is the current status of trial NCT03920215?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2018-08-15. Estimated completion is 2019-09-20.

What conditions does trial NCT03920215 study?

This clinical trial studies the following conditions: Long Term Follow up Dry Eye Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03920215?

The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03920215?

This trial is sponsored by Oyster Point Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03920215 being conducted?

This trial has 3 study locations across California, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial