Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
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|ClinicalTrials.gov Identifier: NCT04957758|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2021
Last Update Posted : November 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Neurotrophic Keratopathy||Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml Drug: Placebo (vehicle) nasal spray||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Actual Study Start Date :||June 17, 2021|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||May 30, 2023|
Active Comparator: OC-01 (varenicline) nasal spray, 1.2 mg/mL
OC-01 (varenicline) nasal spray, 1.2 mg/mL
Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml
Placebo Comparator: Placebo (vehicle control) nasal spray
Placebo (vehicle control) nasal spray
Drug: Placebo (vehicle) nasal spray
- Mean change from baseline in corneal fluorescein staining [ Time Frame: 8 weeks ]Primary Endpoint
- Mean change from baseline in visual acuity at Week 8 [ Time Frame: 8 weeks ]Secondary Endpoint #1
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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): NCT04957758
|Responsible Party:||Oyster Point Pharma, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 12, 2021 Key Record Dates|
|Last Update Posted:||November 16, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs