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

Completed · Phase 2 · Has a placebo group

Conditions studied: Neurotrophic Keratopathy

In brief

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.

Key facts

Study ID

NCT04957758

Run by

Oyster Point Pharma, Inc.

People needed

113

Starts

2021-06-17

Expected to finish

2023-04-28

Last updated by the study team

2024-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dothan Alabama — Dothan, Alabama, United States
• Irvine, California — Irvine, California, United States
• Los Angeles California — Los Angeles, California, United States
• Mission Hills California — Mission Hills, California, United States
• Aurora Colorado — Aurora, Colorado, United States
• Littleton, Colorado — Littleton, Colorado, United States
• Longmont, Colorado — Longmont, Colorado, United States
• Danbury, Connecticut — Danbury, Connecticut, United States
• Brandon Florida — Brandon, Florida, United States
• Brandon, Florida — Brandon, Florida, United States
• Jacksonville Florida — Jacksonville, Florida, United States
• Miami Florida — Miami, Florida, United States
• Atlanta, Georgia — Atlanta, Georgia, United States
• Hoffman Estates, Illinois — Hoffman Estates, Illinois, United States
• Urbana Illinois — Urbana, Illinois, United States
• Union Kentucky — Edgewood, Kentucky, United States
• Louisville KY — Louisville, Kentucky, United States
• Bowie, Maryland — Bowie, Maryland, United States
• Boston Massachusetts — Boston, Massachusetts, United States
• Kansas City Missouri — Kansas City, Missouri, United States
• Henderson Nevada — Henderson, Nevada, United States
• Bloomfield, New Jersey — Bloomfield, New Jersey, United States
• Dover New Jersey — Dover, New Jersey, United States
• Babylon New York — Babylon, New York, United States
• New York NY — New York, New York, United States

Full record on ClinicalTrials.gov

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