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

NCT03920215 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-11-01

Study results available
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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).

Conditions

  • Long Term Follow up Dry Eye Disease

Interventions

DRUG

OC-01 Low Dose, 0.12 mg/mL

OC-01 (varenicline) nasal spray

DRUG

OC-01 Mid Dose, 0.6 mg/mL

OC-01 (varenicline) nasal spray

DRUG

OC-01 High Dose, 1.2 mg/mL

OC-01 (varenicline) nasal spray

DRUG

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Sponsors & Collaborators

  • Oyster Point Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2019-09-20
Completion
2019-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920215 on ClinicalTrials.gov