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)

  • STATUS
    Recruiting
  • days left to enroll
    2
  • sponsor
    Oyster Point Pharma, Inc.
Updated on 10 March 2022

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.

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:
1.    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.

Details
Condition Eye Disease, Eye Disorders/Infections
Clinical Study IdentifierTX292103
SponsorOyster Point Pharma, Inc.
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 with a cotton swab nasal stimulation Schirmer's Test score at least 7 mm greater in the same eye
Have provided verbal and written informed consent
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

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, Fresh Frozen plasma or cord blood derivative tears
Have severe blepharitis and/or severe meibomian gland disease in the study eye
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