Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

NCT03452397 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OPP-001
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 3

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1 (Pre to Post-Treatment Change)

• 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.

  Day 15 (Pre to Post-Treatment Change)

Study Arms (4)

0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)

ACTIVE COMPARATOR

0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)

Drug: 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)

ACTIVE COMPARATOR

1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)

Drug: 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)

ACTIVE COMPARATOR

2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)

Drug: 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)

Placebo (vehicle) nasal spray

PLACEBO COMPARATOR

Placebo (vehicle) nasal spray

Drug: Placebo (vehicle) nasal spray

Interventions

0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) DRUG

0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)

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) DRUG

1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 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) DRUG

2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)

2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)

Placebo (vehicle) nasal spray DRUG

Placebo (vehicle) nasal spray

Placebo (vehicle) nasal spray

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

You may not qualify if:

• 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

Sponsors & Collaborators

• Oyster Point Pharma, Inc.: lead

Study Sites (3)

Louisville

Louisville, Kentucky, 40206, United States

Location

Andover

Andover, Massachusetts, 01810, United States

Location

Nashville

Nashville, Tennessee, 37210, United States

Location

Related Publications (1)

• 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.

  PMID: 35965109 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeffrey Nau
• Organization: Oyster Point Pharma, Inc.

jnau@oysterpointrx.com

609-382-9035

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: February 27, 2018
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)