OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers

NCT05161208 | Completed Phase 4 FDA Drug

• 1 other identifier: OP-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center, prospective, randomized, controlled, double-masked, two-arm investigator-initiated study to investigate the efficacy of OC-01 (varenicline) nasal spray on the signs and symptoms of dry eye disease in daily soft contact lens wearers.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• CLDEQ-8 scores at 4 weeks

  Mean change in CLDEQ-8 scores from baseline to week 4

  4 weeks

• Contact lens wear time at 4 weeks

  Mean change in comfortable wear time, overall wear time, and utilization of artificial tears from baseline to week 4 as measured by virtual daily log

  4 weeks

Secondary Outcomes (5)

• CLDEQ-8 scores at 8 weeks

  8 weeks

• Contact lens wear time at 8 weeks

  8 weeks

• Automated tear breakup time

  8 weeks

• Tearscope tear breakup time

  8 weeks

• Vital staining score

  8 weeks

Study Arms (2)

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

EXPERIMENTAL

Intranasal delivery of OC-01 nasal spray twice daily (BID)

Drug: OC-01 (varenicline 0.6mg/ml) Nasal Spray

Placebo (vehicle) nasal spray

PLACEBO COMPARATOR

Intranasal delivery of placebo vehicle nasal spray twice daily (BID)

Drug: Placebo (vehicle) nasal spray

Interventions

OC-01 (varenicline 0.6mg/ml) Nasal Spray DRUG

Intranasal delivery of OC-01 nasal spray twice daily (BID)

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

Placebo (vehicle) nasal spray DRUG

Intranasal delivery of Placebo (vehicle) nasal spray twice daily (BID)

Placebo (vehicle) nasal spray

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed written consent prior to study-related procedures.
• Be ages 18 to 70 3. Is a symptomatic CL wearer with a CLDEQ-8 score of ≥12 points at baseline at the end of wear time.
• \. Soft contact lens wearers with self-reported complaints of dryness and/or reduced contact lens wear time.
• \. Wear soft contact lenses 2 or more days a week for more than 1 month in both eyes.
• \. Currently wears daily soft lenses in both eyes, for a minimum of 2 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study.
• \. Have a current contact lens prescription. 8. Best corrected visual acuity of 20/25-2 or better in each eye (Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.10 or better in each eye with their habitual contact lens type).
• \. History or current use of artificial tears at least once in the last 30 days.
• \. Be literate and able to complete questionnaires independently. 11. 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 written informed consent. 14. If a female is of childbearing potential, they must not plan to get pregnant during the study.

You may not qualify if:

• Wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer
• Patients with dry eye complaints that the investigator deems are not related to dry eyes will be discontinued at Visit 1.
• Using prescription eyedrops for the treatment of dry eye disease (ex. Steroids, Lifitegrast, Cyclosporine)
• Clinically significant ocular trauma.
• Active or Inactive ocular Herpes simplex or Herpes Zoster infection
• Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
• Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
• Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
• Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
• 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 had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Be currently treated with nasal continuous positive airway pressure
• Have any untreated nasal infection at Visit 1
• Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction.

Sponsors & Collaborators

• Center for Ophthalmic and Vision Research, LLC: lead

Study Sites (1)

Center for Ophthalmic and Vision Recearch

New York, New York, 10022, 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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 17, 2021
• Study Start: December 3, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: November 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)