Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1
Exclusion Criteria:
- Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
- Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
- Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- Have a known hypersensitivity to any of the procedural agents or study drug components
- Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Sites / Locations
- Louisville
- Andover
- Nashville
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
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
Arm Description
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
Outcomes
Primary Outcome Measures
Schirmer's Test Score at Day 1
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.
Eye Dryness Score at Visit 2
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03452397
First Posted
February 26, 2018
Last Updated
November 16, 2021
Sponsor
Oyster Point Pharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03452397
Brief Title
Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
Official Title
Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oyster Point Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Detailed Description
This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
Arm Type
Active Comparator
Arm Description
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
Arm Title
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
Arm Type
Active Comparator
Arm Description
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
Arm Title
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Arm Type
Active Comparator
Arm Description
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Arm Title
Placebo (vehicle) nasal spray
Arm Type
Placebo Comparator
Arm Description
Placebo (vehicle) nasal spray
Intervention Type
Drug
Intervention Name(s)
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
Intervention Description
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
Intervention Type
Drug
Intervention Name(s)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
Intervention Description
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
Intervention Type
Drug
Intervention Name(s)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Intervention Description
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Intervention Type
Drug
Intervention Name(s)
Placebo (vehicle) nasal spray
Intervention Description
Placebo (vehicle) nasal spray
Primary Outcome Measure Information:
Title
Schirmer's Test Score at Day 1
Description
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.
Time Frame
Day 1 (Pre to Post-Treatment Change)
Title
Eye Dryness Score at Visit 2
Description
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.
Time Frame
Day 15 (Pre to Post-Treatment Change)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1
Exclusion Criteria:
Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
Have a known hypersensitivity to any of the procedural agents or study drug components
Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
Facility Information:
Facility Name
Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35965109
Citation
Torkildsen GL, Pattar GR, Jerkins G, Striffler K, Nau J. Efficacy and Safety of Single-dose OC-02 (Simpinicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The PEARL Phase II Randomized Trial. Clin Ther. 2022 Sep;44(9):1178-1186. doi: 10.1016/j.clinthera.2022.07.006. Epub 2022 Aug 11.
Results Reference
derived
Learn more about this trial
Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
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