CompletedPhase 2

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

United States113 participantsStarted 2021-06-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.
✓. 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, cenegermin, fresh frozen plasma or cord blood derivative tears.
✕. Have severe blepharitis and/or severe meibomian gland disease in the study eye.

What they're measuring

Mean Change From Baseline in Corneal Fluorescein Staining

Timeframe: 8 weeks

Trial details

NCT IDNCT04957758

SponsorOyster Point Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-27

Results submitted2024-03-08

View on ClinicalTrials.gov More Neurotrophic Keratopathy trials