Clinical Trial to Evaluate the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)
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| ClinicalTrials.gov Identifier: NCT04036292 |
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Recruitment Status :
Completed
First Posted : July 29, 2019
Last Update Posted : February 21, 2021
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Sponsor:
Oyster Point Pharma, Inc.
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.
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Brief Summary:
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 (DED)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Disease (DED) | Drug: OC-01 Drug: Placebos | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 758 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study) |
| Actual Study Start Date : | July 23, 2019 |
| Actual Primary Completion Date : | May 8, 2020 |
| Actual Study Completion Date : | February 17, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eye Diseases
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: OC-01 Low Dose |
Drug: OC-01
OC-01 |
| Active Comparator: OC-01 High Dose |
Drug: OC-01
OC-01 |
| Placebo Comparator: Placebo |
Drug: Placebos
Placebo |
Primary Outcome Measures :
- Schirmer's Test [ Time Frame: 28 Days ]Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to day 28
Secondary Outcome Measures :
- Mean change from Baseline in Eye Dryness Score (EDS) in the study eye at 5 minutes in the CAE® [ Time Frame: 28 Days ]Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
- Mean change from Baseline in Eye Dryness Score (EDS) in the study eye at Week 4 [ Time Frame: 28 Days ]Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
- Mean change from Baseline in Schirmer's Test Score (STS) in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Schirmer's Test Score (STS) in the study eye
- Mean change from Baseline in Inferior Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Inferior Corneal Fluorescein Staining in the study eye
- Mean change from Baseline in Eye Dryness Score (EDS) in the study eye at Week 2 [ Time Frame: 14 Days ]Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
- Mean change from Baseline in Eye Dryness Score (EDS) in the study eye at Week 1 [ Time Frame: 7 Days ]Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
- Mean change from Baseline in Nasal Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Nasal Corneal Fluorescein Staining in the study eye
- Mean change from Baseline in Temporal Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Temporal Corneal Fluorescein Staining in the study eye
- Mean change from Baseline in Central Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Central Corneal Fluorescein Staining in the study eye
- Mean change from Baseline in Superior Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Superior Corneal Fluorescein Staining in the study eye
- Mean change from Baseline in Total Corneal Fluorescein Staining in the study eye at Week 4 [ Time Frame: 28 Days ]Mean change from Baseline in Total Corneal Fluorescein Staining in the study eye
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036292
Locations
Show 22 study locations
Sponsors and Collaborators
Oyster Point Pharma, Inc.
| Responsible Party: | Oyster Point Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT04036292 |
| Other Study ID Numbers: |
OPP-101 |
| First Posted: | July 29, 2019 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |