Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)

NCT05082974 | Completed Phase 3 FDA Drug

• 1 other identifier: The RANK Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray for amelioration of signs and symptoms of dry eye disease in subjects following laser-assisted in situ keratomileusis (LASIK).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score

  25 questions to determine overall score of dry eye disease symptoms completed by subject. Scored from 0-100, with 100 being the highest score and best outcome.

  Baseline to Day 84 (3 months)

• Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp

  Evaluated at slit lamp by a masked physician

  Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)

Secondary Outcomes (7)

• Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score

  Baseline to Day 184 (6 months)

• Mean change in eye dryness score (EDS)

  Baseline to Day 184 (6 months)

• Mean change in residual refractive error

  Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month) postoperative LASIK

• Change in tear collection lab values

  Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month)

• Mean change tear break-up time

  baseline to Day 0 (Surgical Day), Day 28 (1-month) postoperative LASIK and Day 84 (3-month) postoperative LASIK

Study Arms (2)

OC-01 (varenicline 0.6mg/ml) nasal spray

EXPERIMENTAL

Drug: OC-01 (varenicline 0.6mg/ml) nasal spray

Placebo (vehicle) nasal spray

PLACEBO COMPARATOR

Drug: Placebo (vehicle) nasal spray

Interventions

OC-01 (varenicline 0.6mg/ml) nasal spray DRUG

OC-01 (varenicline 0.6mg/ml) nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of Drye Eye Disease. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production to bathe the corneal nerve endings in a protective layer of tear film. In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway.

OC-01 (varenicline 0.6mg/ml) nasal spray

Placebo (vehicle) nasal spray DRUG

Placebo (vehicle) nasal spray \[control\]

Placebo (vehicle) nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to sign the informed consent form (ICF)
• Be at least 18 years of age at the screening visit
• Be undergoing LASIK treatment in one or both eyes
• Be myopic between -1.00D to -7.00D MRSE (manifest refraction spherical equivalent) in study eye (right eye) with ≤2D between eyes or subjects undergoing monovision treatment with study eye (distance eye) meeting the diopter requirement of myopia
• Be literate and able to complete questionnaires independently
• Be able and willing to use the study drug and participate in all study assessments and visits
• Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug
• 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 baseline

You may not qualify if:

• Subjects must not:
• Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect, or corneal ulcer.
• Have presence of corneal pathology that may interfere with LASIK outcomes
• Active infectious, ocular or systemic disease
• Have a history of ocular inflammation or macular edema
• Have had clinically significant active infectious keratitis in the past 3 months
• Have history of prior refractive surgery
• Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
• Have chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to clinically significant risk of increased bleeding
• Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction as confirmed by intranasal examination performed at Visit 1.
• Be currently treated with nasal continuous positive airway pressure
• Have had blepharoplasty in either eye
• Have had a corneal transplant in either eye
• Have a history of seizures or other factors that lower the subject's seizure threshold.

Sponsors & Collaborators

• Vance Thompson Vision ND: lead

Study Sites (1)

Vance Thompson Vision ND

West Fargo, North Dakota, 58078, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: October 20, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

US (1)