22 and older, any sex, with Dry Eye Disease (DED). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)Primary· 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
123
OC-01 High Dose, 1.2 mg/mL
121
Placebo (Vehicle) Nasal Spray
70
Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 MinutesSecondary· 28 Days [Visit 1 (baseline) and Visit 4a (28 days)]
Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
-10.3
± 1.62
OC-01 High Dose, 1.2 mg/mL
-9.0
± 1.75
Placebo
-7.4
± 1.74
Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28Secondary· 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
-19.8
± 1.54
OC-01 High Dose, 1.2 mg/mL
-22.2
± 1.61
Placebo
-15.4
± 1.57
Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28Secondary· 28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
11.3
± 0.61
OC-01 High Dose, 1.2 mg/mL
11.5
± 0.64
Placebo
6.3
± 0.61
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2Secondary· 14 Days [Visit 1 (baseline) and Visit 3 (14 days)]
Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
-16.5
± 1.38
OC-01 High Dose, 1.2 mg/mL
-17.9
± 1.45
Placebo
-12.7
± 1.41
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1Secondary· 7 Days [Visit 1 (baseline) and Visit 2 (7 days)]
Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Group
Value
95% CI
OC-01 Low Dose, 0.6 mg/mL
-15.7
± 1.33
OC-01 High Dose, 1.2 mg/mL
-15.4
± 1.40
Placebo
-13.3
± 1.35
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 7.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
OC-01 Low Dose, 0.6 mg/mL
Serious: 5/260 (2%)
Deaths: 0/260
OC-01 High Dose, 1.2 mg/mL
Serious: 12/245 (5%)
Deaths: 2/245
Placebo
Serious: 9/251 (4%)
Deaths: 1/251
Serious adverse events (26 terms)
Reaction
System
OC-01 Low Dose, 0.6 mg/mL
OC-01 High Dose, 1.2 mg/mL
Placebo
Coronavirus infection
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Diabetic gangrene
Infections and infestations
—
—
—
Gangrene
Infections and infestations
—
—
—
Osteomyelitis
Infections and infestations
—
—
—
Pneumonia
Infections and infestations
—
—
—
Pneumonia bacterial
Infections and infestations
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Atrioventricular block complete
Cardiac disorders
—
—
—
Bradycardia
Cardiac disorders
—
—
—
Coronary artery disease
Cardiac disorders
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
—
—
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
—
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03688802 — Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
· Phase 2
· completed
NCT03636061 — Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
· Phase 2
· completed
Other recruiting trials for Dry Eye Disease (DED)
Currently open trials in the same condition.
NCT07243275 — SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
· Phase 4
· recruiting
NCT07234318 — A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyc
· active not recruiting
NCT07396441 — Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye
· Phase 4
· recruiting
NCT06955806 — Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
· NA
· active not recruiting
NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy
· NA
· recruiting
Other Oyster Point Pharma, Inc. trials
Trials by the same sponsor.
NCT06329687 — A Study Evaluating the Safety of the Nasal Pump
· Phase 4
· terminated
NCT05918406 — Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya
· Phase 4
· completed
NCT04957758 — Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
· Phase 2
· completed
NCT04072146 — Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
· Phase 1
· completed
NCT03873246 — Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oyster Point Pharma, Inc.
Last refreshed: 22 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04036292.