Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04957758
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

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.

Layout table for study information
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 : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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)




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

  2. Percentage of subjects that progress to Stage 2 Persistent Epithelial Defect (PED) NK at Week 8 [ Time Frame: 8 weeks ]
    Secondary Endpoint #2

  3. Improvement in corneal sensitivity at Week 8 [ Time Frame: 8 weeks ]
    Secondary Endpoint #3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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


Contacts
Layout table for location contacts
Contact: Marian Macsai (312) 259-2477 mmacsai@oysterpointrx.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Oyster Point Pharma, Inc.
Layout table for additonal information
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: June 21, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs