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Clinical Trial to Evaluate the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920215
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

Study Description
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Brief Summary:
The objective of this safety long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.

Condition or disease Intervention/treatment Phase
Long Term Follow up Drug: Observational OC-01 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET Study)-Long Term Safety Follow-up
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : October 12, 2019
Actual Study Completion Date : October 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Comparator: OC-01 Low Dose Drug: Observational OC-01
long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.
Experimental: Active Comparator: OC-01 Mid Dose Drug: Observational OC-01
long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.
Experimental: Active Comparator: OC-01 High Dose Drug: Observational OC-01
long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.
Experimental: Placebo Comparator: Placebo Drug: Observational OC-01
long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.


Outcome Measures
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Primary Outcome Measures :
  1. to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study. [ Time Frame: 12 months ]
    presence of new or changes to adverse events in the observation period


Eligibility Criteria
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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:

  1. Have been enrolled in the OPP-002 study
  2. Have received at least one dose of the study drug/placebo in OPP-002 study
  3. Completed the OPP-002 study to Visit 5
  4. Have provided verbal and written informed consent

Exclusion Criteria:

1. Have discontinued prior to Visit 5 in the OPP-002 study.

Contacts and Locations
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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): NCT03920215


Locations
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United States, California
Newport Beach
Newport Beach, California, United States, 92663
United States, Indiana
Indianapolis
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Andover
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Oyster Point Pharma, Inc.
More Information
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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03920215    
Other Study ID Numbers: OPP-002-01EXT
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Eye Diseases
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases