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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
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

Study Description
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Brief 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 or both eyes.

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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
OC-01
Placebo Comparator: Placebo (vehicle control) nasal spray
Placebo (vehicle control) nasal spray
 Drug: Placebo (vehicle) nasal spray
Placebo (vehicle)


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in corneal fluorescein staining [ Time Frame: 8 weeks ]
    Primary Endpoint


Secondary Outcome Measures :
  1. Mean change from baseline in visual acuity at Week 8 [ Time Frame: 8 weeks ]
    Secondary Endpoint #1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 18 years of age at Visit 1.
  2. Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
  3. Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
  4. Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
  5. 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.

Exclusion Criteria:

  1. Have Stage 2 or Stage 3 NK affecting one or both eyes.
  2. Have ocular graft versus host disease or Stevens-Johnson syndrome.
  3. 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.
  4. Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
  5. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
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): NCT04957758


Locations
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Sponsors and Collaborators
Oyster Point Pharma, Inc.
More Information
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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04957758    
Other Study ID Numbers: OPP-102
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022

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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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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs