Long Term Follow up Dry Eye DiseasePhase 2/3NCT03920215
Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
A Phase 2/3 study testing OC-01 Low Dose, 0.12 mg/mL, OC-01 Mid Dose, 0.6 mg/mL and OC-01 High Dose, 1.2 mg/mL in people with Long Term Follow up Dry Eye Disease, run by Oyster Point Pharma, Inc. at 3 sites in United States.
Trial summary
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Long Term Follow up Dry Eye Disease
- What is being tested?
- OC-01 Low Dose, 0.12 mg/mL, OC-01 Mid Dose, 0.6 mg/mL and OC-01 High Dose, 1.2 mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2018to 20 Sep 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been enrolled in the OPP-002 study
- Have received at least one dose of the study drug/placebo in OPP-002 study
- Completed the OPP-002 study to Visit 5
- Have provided verbal and written informed consent
Who cannot join
- 1. Have discontinued prior to Visit 5 in the OPP-002 study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover
Andover, Massachusetts, 01810
Indianapolis
Indianapolis, Indiana, 46290
Newport Beach
Newport Beach, California, 92663
About this study
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
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
Read the detailed description
Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.
The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
- Conditions
- Long Term Follow up Dry Eye Disease
- Being tested
- OC-01 Low Dose, 0.12 mg/mL, OC-01 Mid Dose, 0.6 mg/mL, OC-01 High Dose, 1.2 mg/mL, Placebo (vehicle) nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC-01 Low Dose, 0.12 mg/mLDrug
Also called OC-01 (varenicline) nasal spray, 0.12 mg/ml
OC-01 (varenicline) nasal spray
OC-01 Mid Dose, 0.6 mg/mLDrug
OC-01 (varenicline) nasal spray
OC-01 High Dose, 1.2 mg/mLDrug
Also called OC-01 Mid Dose, 1.2 mg/mL
OC-01 (varenicline) nasal spray
Placebo (vehicle) nasal sprayDrug
Placebo (vehicle) nasal spray
| Study group | Role | What they receive |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Active comparator | OC-01 (varenicline) nasal spray, 0.12 mg/mL Receives: Drug: OC-01 Low Dose, 0.12 mg/mL |
| OC-01 Mid Dose, 0.6 mg/mL | Active comparator | OC-01 (varenicline) nasal spray, 0.60 mg/mL Receives: Drug: OC-01 Mid Dose, 0.6 mg/mL |
| OC-01 High Dose, 1.2 mg/mL | Active comparator | OC-01 (varenicline) nasal spray, 1.2 mg/mL Receives: Drug: OC-01 High Dose, 1.2 mg/mL |
| Placebo (vehicle) nasal spray | Placebo comparator | Placebo (vehicle) nasal spray Receives: Drug: Placebo (vehicle) nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Measured: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Measured: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Measured: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Measured: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start15 Aug 2018
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long Term Follow up Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oyster Point Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920215
- Sponsor's protocol ID
- OPP-002-01EXT
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2019
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03920215
- Acronym / sponsor ID
- OPP-002-01EXT
- Conditions
- Long Term Follow up Dry Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Oyster Point Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 22 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
Detailed description
Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.
The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mL | Active comparator | Drug: OC-01 Low Dose, 0.12 mg/mLOC-01 (varenicline) nasal spray, 0.12 mg/mL |
| OC-01 Mid Dose, 0.6 mg/mL | Active comparator | Drug: OC-01 Mid Dose, 0.6 mg/mLOC-01 (varenicline) nasal spray, 0.60 mg/mL |
| OC-01 High Dose, 1.2 mg/mL | Active comparator | Drug: OC-01 High Dose, 1.2 mg/mLOC-01 (varenicline) nasal spray, 1.2 mg/mL |
| Placebo (vehicle) nasal spray | Placebo comparator | Drug: Placebo (vehicle) nasal sprayPlacebo (vehicle) nasal spray |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been enrolled in the OPP-002 study
- Have received at least one dose of the study drug/placebo in OPP-002 study
- Completed the OPP-002 study to Visit 5
- Have provided verbal and written informed consent
Key exclusion criteria (1 listed)
- 1. Have discontinued prior to Visit 5 in the OPP-002 study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OC-01 Low Dose, 0.12 mg/mLAlso: OC-01 (varenicline) nasal spray, 0.12 mg/mlOC-01 (varenicline) nasal spray | Drug | OC-01 Low Dose, 0.12 mg/mL |
| OC-01 Mid Dose, 0.6 mg/mLOC-01 (varenicline) nasal spray | Drug | OC-01 Mid Dose, 0.6 mg/mL |
| OC-01 High Dose, 1.2 mg/mLAlso: OC-01 Mid Dose, 1.2 mg/mLOC-01 (varenicline) nasal spray | Drug | OC-01 High Dose, 1.2 mg/mL |
| Placebo (vehicle) nasal sprayPlacebo (vehicle) nasal spray | Drug | Placebo (vehicle) nasal spray |
Primary outcome
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Time frame: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations
Time frame: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)
Number of Participants with the Right Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Time frame: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Number of Participants with the Left Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations
Time frame: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)
Number of Participants with the Right Nostril/Abnormal at 12 months as assessed by Intranasal Examinations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OC-01 Low Dose, 0.12 mg/mL, OC-01 Mid Dose, 0.6 mg/mL and OC-01 High Dose, 1.2 mg/mL in people with Long Term Follow up Dry Eye Disease, run by Oyster Point Pharma, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations (time frame: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.