Trials Sponsors Conditions Drugs Pricing

Conditions

Neurotrophic Keratopathy

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline in Corneal Fluorescein Staining
Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).
8 weeks

Secondary Outcomes (1)

Mean Change From Baseline in Visual Acuity at Week 8
8 weeks

Study Arms (2)

OC-01 (varenicline) nasal spray, 1.2 mg/mL

ACTIVE COMPARATOR

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml

Placebo (vehicle control) nasal spray

PLACEBO COMPARATOR

Placebo (vehicle control) nasal spray

Drug: Placebo (vehicle) nasal spray

Interventions

OC-01 (varenicline) nasal spray 1.2 mg/mlDrug

OC-01

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Placebo (vehicle) nasal sprayDrug

Placebo (vehicle)

Placebo (vehicle control) nasal spray

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

Oyster Point Pharma, Inc.
Industrylead

Study Sites (31)

Dothan Alabama

Dothan, Alabama, 36301, United States

Irvine, California

Irvine, California, 92697, United States

Los Angeles California

Los Angeles, California, 90095, United States

Mission Hills California

Mission Hills, California, 91345, United States

Aurora Colorado

Aurora, Colorado, 80045, United States

Littleton, Colorado

Littleton, Colorado, 80120, United States

Longmont, Colorado

Longmont, Colorado, 80503, United States

MeSH Terms

Interventions

VareniclineNasal Sprays

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title: Marian Macsai, MD
Organization: Oyster Point Pharma Inc

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

113 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 12, 2021

Study Start

June 17, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Placebo (vehicle control) nasal spray

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Placebo (vehicle control) nasal spray

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations