IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL

NCT05136924 | Unknown Phase 2 FDA Drug

• 1 other identifier: The CIrCles Study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated study to Assess the Efficacy of OC-01 (varenicline) Nasal Spray on signs and symptoms of Dry Eye Disease in subjects following Corneal Collagen Crosslinking (CXL)

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• NEI VFQ-25 Questionnaire

  questionnaire assesses effect of visual impairment on the patient's current health-related quality of life, including questions dealing with irritation in and around the eye. The score on a scale is from 0 to 100 points. A score of 0 is the worst score and a score of 100 is the best score and means the patient has no vision problems

  from baseline to Day 28 (1-month postoperative CXL)

• Corneal Epithelial Healing

  Corneal epithelial healing rate at days 2 (48 hours), 3 (72 hours), 4 (96 hours) after creation of 9mm epithelial defect as measured by a masked physician

  Up to 96 hours after creation of 9mm epithelial defect

Secondary Outcomes (4)

• Dryness Scoring

  from baseline over time to Day 28 (1 month postoperatively CXL)

• Corneal Fluorescein Staining

  from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)

• Tear Break Up Time

  baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)

• Adverse Events

  56 days (4 weeks preop and 4 weeks postop)

Study Arms (2)

OC-01

EXPERIMENTAL

(varenicline 1.2mg/ml) nasal spray

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

Placebo

PLACEBO COMPARATOR

(vehicle) nasal spray

Other: Placebo (vehicle) nasal spray

Interventions

OC-01 (varenicline 1.2mg/ml) nasal spray vs Placebo DRUG

OC-01 nasal spray containing varenicline for treatment of signs and symptoms of DED. 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 VS Placebo

Also known as: Placebo (vehicle) nasal spray

OC-01

Placebo (vehicle) nasal spray OTHER

Placebo (vehicle) nasal spray

Placebo

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
• Be at least 18 to 50 years of age at the screening visit
• Have best corrected manifest refraction between 20/40 to 20/100
• Remove contact lenses 2 weeks prior to surgical procedure and continue until end of study with the exception of scleral lens wearers that have no better option for correcting visual acuity
• Have planned corneal collagen crosslinking for treatment of keratoconus or corneal ectasia
• 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/Screening Day

You may not qualify if:

• Have presence of corneal pathology that may interfere with CXL outcomes
• At time of screening have had temporary plugs placed in the past 1 month or currently have permanent punctal plugs in place
• Active infectious, ocular, or systemic disease
• Have a history of ocular inflammation or macular edema
• 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.
• 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 current concomitant use of a nicotinic acetylcholine receptor agonist \[Nicoderm®, Nicorette®, Nicotrol NS® (nicotine), Tabex®, Desmoxan® (cytisine), and Chantix® (varenicline)\] within the previous 30 days of Visit 1 and during the treatment period.
• Have active or uncontrolled, severe (at the discretion of the investigator):
• Systemic allergy

Sponsors & Collaborators

• Vance Thompson Vision - MT: lead

Study Sites (1)

Vance Thompson Vision-MT

Bozeman, Montana, 59718, United States

Location

Related Publications (1)

• Ferguson TJ, Durgan D, Whitt T, Swan RJ. Varenicline Nasal Spray for the Treatment of Dry Eye Disease Following Corneal Collagen Crosslinking. Ophthalmol Ther. 2025 May;14(5):959-968. doi: 10.1007/s40123-025-01118-x. Epub 2025 Mar 15.

  PMID: 40088395 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated studyOC-01 (varenicline 1.2mg/ml) nasal spray Or Placebo (vehicle) nasal spray
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: OC-01 (varenicline 1.2mg/ml) nasal spray Or Placebo (vehicle) nasal spray

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 30, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

US (1)