Trial · NCT03452397
Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
NCT03452397, Phase 2, Completed, Oyster Point Pharma, Inc.; results first posted 2021-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study). Trials, record NCT03452397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03452397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
- NCT number
- NCT03452397
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 165 participants, actual
- Lead sponsor
- Oyster Point Pharma, Inc.
- Conditions
- Dry Eye Disease
- Interventions
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL), 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL), 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL), Placebo (vehicle) nasal spray
- First posted
- 2018-03-02
- Last updated
- 2021-12-14
- Results first posted
- 2021-12-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Schirmer's Test Score at Day 1 | Day 1 (Pre to Post-Treatment Change) | The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome. |
| Primary | Eye Dryness Score at Visit 2 | Day 15 (Pre to Post-Treatment Change) | Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Schirmer's Test Score at Day 1 | Day 1 (Pre to Post-Treatment Change) | Subjects in the ITT population | mm | LEAST_SQUARES_MEAN |
| PRIMARY | Eye Dryness Score at Visit 2 | Day 15 (Pre to Post-Treatment Change) | Subjects in the ITT Population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics | mm | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Schirmer's Test Score at Day 1 | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 9.0 | 95% Confidence Interval 6.3 to 11.6 | mm | |
| Schirmer's Test Score at Day 1 | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 17.5 | 95% Confidence Interval 14.8 to 20.2 | mm | |
| Schirmer's Test Score at Day 1 | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 19.6 | 95% Confidence Interval 16.9 to 22.3 | mm | |
| Schirmer's Test Score at Day 1 | Placebo (Vehicle) Nasal Spray | 3.0 | 95% Confidence Interval 0.3 to 5.6 | mm | |
| Eye Dryness Score at Visit 2 | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | -9.4 | 95% Confidence Interval -15.4 to -3.5 | mm | |
| Eye Dryness Score at Visit 2 | 1 % Hemigalactarate (0.11% Free Base) 1 % OC-02 Mid Dose (5.5 mg/mL) | -17.4 | 95% Confidence Interval -23.1 to -11.7 | mm | |
| Eye Dryness Score at Visit 2 | 2 % Hemigalactarate (0.11% Free Base) 2 % OC-02 High Dose (11.1 mg/mL) | -20.7 | 95% Confidence Interval -26.7 to -14.7 | mm | |
| Eye Dryness Score at Visit 2 | Placebo (Vehicle) Nasal Spray | -6.5 | 95% Confidence Interval -12.1 to -0.8 | mm |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) | 41 | |
| Overall Study | STARTED | 1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL) | 41 | |
| Overall Study | STARTED | 2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL) | 41 | |
| Overall Study | STARTED | Placebo (Vehicle) Nasal Spray | 42 | |
| Overall Study | COMPLETED | 0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) | 40 | |
| Overall Study | COMPLETED | 1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL) | 41 | |
| Overall Study | COMPLETED | 2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL) | 39 | |
| Overall Study | COMPLETED | Placebo (Vehicle) Nasal Spray | 41 | |
| Overall Study | NOT COMPLETED | 0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL) | 1 | |
| Overall Study | NOT COMPLETED | 1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye pruritus | Eye disorders | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0 | 41 | |
| other | Eye pruritus | Eye disorders | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 0 | 41 | |
| other | Eye pruritus | Eye disorders | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 1 | 41 | |
| other | Eye pruritus | Eye disorders | Placebo (Vehicle) Nasal Spray | 0 | 42 | |
| other | Keratits | Eye disorders | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0 | 41 | |
| other | Keratits | Eye disorders | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 1 | 41 | |
| other | Keratits | Eye disorders | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 0 | 41 | |
| other | Keratits | Eye disorders | Placebo (Vehicle) Nasal Spray | 0 | 42 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 8 | 41 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 10 | 41 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 0 | 41 |
| Total, all-cause mortality | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 0 | 41 |
| Total, all-cause mortality | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 0 | 41 |
| Total, all-cause mortality | Placebo (Vehicle) Nasal Spray | 0 | 42 |
| Total, other adverse events | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 17 | 41 |
| Total, other adverse events | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 23 | 41 |
| Total, other adverse events | 2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) | 24 | 41 |
| Total, other adverse events | Placebo (Vehicle) Nasal Spray | 4 | 42 |
| Total, serious adverse events | 0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) | 1 | 41 |
| Total, serious adverse events | 1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) | 0 | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35965109 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03452397
GET https://conductscience.org/api/trials/v1/NCT03452397/events?page=2