Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

NCT03688802 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OPP-005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (6)

• Mean Change in Goblet Cell Area

  Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.

  Baseline (pre-treatment), 1 day (post treatment)

• Mean Change in Goblet Cell Perimeter

  Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.

  Baseline (pre-treatment), 1 day (post treatment)

• Change in Meibomian Gland Area, Upper Lid

  Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome

  Baseline (pre-treatment), 1 day (post treatment)

• Mean Change in Meibomian Gland Area, Lower Lid.

  Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.

  Baseline (pre-treatment), 1 day (post treatment)

• Mean Change in Meibomian Gland Perimeter, Upper Lid.

  Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.

  Baseline (pre-treatment), 1 day (post treatment)

• Mean Change in Meibomian Gland Perimeter, Lower Lid

  Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.

  Baseline (pre-treatment), 1 day (post treatment)

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: OC-01 (varenicline) nasal spray

Placebo (vehicle control) nasal spray

PLACEBO COMPARATOR

Placebo (vehicle control) nasal spray, one time dosing

Drug: Placebo (vehicle control) nasal spray

Interventions

OC-01 (varenicline) nasal spray DRUG

OC-01 (varenicline) nasal spray

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

Placebo (vehicle control) nasal spray DRUG

Placebo

Placebo (vehicle control) nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1.

You may not qualify if:

• Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
• Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
• Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
• Have a known hypersensitivity to any of the procedural agents or study drug components
• Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

Sponsors & Collaborators

• Oyster Point Pharma, Inc.: lead

Study Sites (1)

Tufts

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Dieckmann GM, Cox SM, Lopez MJ, Ozmen MC, Yavuz Saricay L, Bayrakutar BN, Binotti WW, Henry E, Nau J, Hamrah P. A Single Administration of OC-01 (Varenicline Solution) Nasal Spray Induces Short-Term Alterations in Conjunctival Goblet Cells in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1551-1561. doi: 10.1007/s40123-022-00530-x. Epub 2022 Jun 2.

  PMID: 35653029 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Varenicline; Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeffrey Nau
• Organization: Oyster Point Pharma, Inc.

jnau@oysterpointrx.com

609-382-9035

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: September 26, 2018
• First Posted: September 28, 2018
• Study Start: September 25, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 29, 2021
• Results First Posted: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)