Neurotrophic KeratopathyPhase 2NCT04957758
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
A Phase 2 study testing OC-01 (varenicline) nasal spray 1.2 mg/ml in people with Neurotrophic Keratopathy, run by Oyster Point Pharma, Inc. at 31 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratopathy
- What is being tested?
- OC-01 (varenicline) nasal spray 1.2 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 31 sitesUnited States
- Study dates
- 17 Jun 2021to 28 Apr 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age at Visit 1.
- Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
- Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
- Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
- If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.
Who cannot join
- Have Stage 2 or Stage 3 NK affecting one or both eyes.
- Have ocular graft versus host disease or Stevens-Johnson syndrome.
- Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
- Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
- Have severe blepharitis and/or severe meibomian gland disease in the study eye.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Atlanta, Georgia
Atlanta, Georgia, 30339
Aurora Colorado
Aurora, Colorado, 80045
Babylon New York
Babylon, New York, 11702
Bloomfield, New Jersey
Bloomfield, New Jersey, 07003
Boston Massachusetts
Boston, Massachusetts, 02114
Bowie, Maryland
Bowie, Maryland, 20716
Brandon Florida
Brandon, Florida, 33511
Brandon, Florida
Brandon, Florida, 33511
Danbury, Connecticut
Danbury, Connecticut, 06810
Dothan Alabama
Dothan, Alabama, 36301
Dover New Jersey
Dover, New Jersey, 07801
Union Kentucky
Edgewood, Kentucky, 41017
Henderson Nevada
Henderson, Nevada, 89052
Hoffman Estates, Illinois
Hoffman Estates, Illinois, 60169
Houston Texas
Houston, Texas, 77030
Irvine, California
Irvine, California, 92697
Jacksonville Florida
Jacksonville, Florida, 32256
Kansas City Missouri
Kansas City, Missouri, 64111
Katy, Texas
Katy, Texas, 77494
Littleton, Colorado
Littleton, Colorado, 80120
Longmont, Colorado
Longmont, Colorado, 80503
Los Angeles California
Los Angeles, California, 90095
Louisville KY
Louisville, Kentucky, 40206
Lynchburg Virginia
Lynchburg, Virginia, 24502
Miami Florida
Miami, Florida, 33136
Mission Hills California
Mission Hills, California, 91345
New York NY
New York, New York, 10029
San Antonio Texas
San Antonio, Texas, 78229
Seattle Washington
Seattle, Washington, 98119
Urbana Illinois
Urbana, Illinois, 61801
York, Pennsylvania
York, Pennsylvania, 17408
About this study
Official title: A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
Read the detailed description
Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:
- OC-01 (varenicline) nasal spray, 1.2 mg/mL
- Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.
- Conditions
- Neurotrophic Keratopathy
- Being tested
- OC-01 (varenicline) nasal spray 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 (varenicline) nasal spray 1.2 mg/mlDrug
OC-01
Placebo (vehicle) nasal sprayDrug
Placebo (vehicle)
| Study group | Role | What they receive |
|---|---|---|
| OC-01 (varenicline) nasal spray, 1.2 mg/mL | Active comparator | OC-01 (varenicline) nasal spray, 1.2 mg/mL Receives: Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml |
| Placebo (vehicle control) nasal spray | Placebo comparator | Placebo (vehicle control) 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.
Mean Change From Baseline in Corneal Fluorescein Staining
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
Measured: 8 weeks
Secondary outcomes (1)
Mean Change From Baseline in Visual Acuity at Week 8
Best Corrected Visual Acuity was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS letters score range from 0 to 100 letters at each assessment.
A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start17 Jun 2021
- Primary completion27 Jan 2023
- Study completion28 Apr 2023
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 Neurotrophic KeratopathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 113 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
- NCT04957758
- Sponsor's protocol ID
- OPP-102
- Status last verified
- Mar 2024
- First submitted
- 28 Jun 2021
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)
- ClinicalTrials.gov ID
- NCT04957758
- Acronym / sponsor ID
- OPP-102
- Conditions
- Neurotrophic Keratopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Oyster Point Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 7 May 2024
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 study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.
Detailed description
Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:
- OC-01 (varenicline) nasal spray, 1.2 mg/mL
- Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC-01 (varenicline) nasal spray, 1.2 mg/mL | Active comparator | Drug: OC-01 (varenicline) nasal spray 1.2 mg/mlOC-01 (varenicline) nasal spray, 1.2 mg/mL |
| Placebo (vehicle control) nasal spray | Placebo comparator | Drug: Placebo (vehicle) nasal sprayPlacebo (vehicle control) nasal spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years of age at Visit 1.
- Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
- Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
- Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
- If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.
Key exclusion criteria (5 listed)
- Have Stage 2 or Stage 3 NK affecting one or both eyes.
- Have ocular graft versus host disease or Stevens-Johnson syndrome.
- Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
- Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
- Have severe blepharitis and/or severe meibomian gland disease in the study eye.
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 (varenicline) nasal spray 1.2 mg/mlOC-01 | Drug | OC-01 (varenicline) nasal spray, 1.2 mg/mL |
| Placebo (vehicle) nasal sprayPlacebo (vehicle) | Drug | Placebo (vehicle control) nasal spray |
Primary outcome
Mean Change From Baseline in Corneal Fluorescein Staining
Time frame: 8 weeks
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
1 secondary outcome
Mean Change From Baseline in Visual Acuity at Week 8
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OC-01 (varenicline) nasal spray 1.2 mg/ml in people with Neurotrophic Keratopathy, run by Oyster Point Pharma, Inc. at 31 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 5 inclusion and 5 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 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.
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 7 May 2024). 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?
Mean Change From Baseline in Corneal Fluorescein Staining (time frame: 8 weeks). 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 7 May 2024.