Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)

NCT03873246 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-06-08

Study results available
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Summary

The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED).

Conditions

Interventions

DRUG

OC-01 0.1% 0.6 mg/ml

OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml)

DRUG

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml)

OTHER

placebo comparator

vehicle control

Sponsors & Collaborators

  • Oyster Point Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2020-01-07
Completion
2020-01-07

Countries

  • Mexico

Study Locations

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Entities

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 NCT03873246 on ClinicalTrials.gov