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Dry EyePhase 4NCT05161208

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

A Phase 4 study testing OC-01 (varenicline 0.6mg/ml) Nasal Spray in people with Dry Eye, run by Center for Ophthalmic and Vision Research, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
OC-01 (varenicline 0.6mg/ml) Nasal Spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteUnited States
Study dates
3 Dec 2021to 25 Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 4. Soft contact lens wearers with self-reported complaints of dryness and/or reduced contact lens wear time.
  • 5. Wear soft contact lenses 2 or more days a week for more than 1 month in both eyes.
  • 6. 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.
  • 7. 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).
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  • 9. History or current use of artificial tears at least once in the last 30 days.
  • 10. 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.
  • 12. Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug.
  • 13. Have provided written informed consent. 14. If a female is of childbearing potential, they must not plan to get pregnant during the study.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Use of topical presecription ophthalmic medications including cyclosporine, liftegrast, steroids, non-steroidal anti-inflammatory drugs, anti-glaucoma medications within 7 days of screening or during study period.
  • Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days of screening and throughout study period (systemic permitted.)
  • Have a known hypersensitivity to any of the procedural agents or study drug components
  • Have active or uncontrolled, severe at the discretion of the investigator: (a) Systemic allergy, (b) Chronic seasonal allergies at risk of being active during the study treatment period, (c) Rhinitis or sinusitis requiring treatment such as antihistamines, decongestants, oral or aerosol steroids at the Screening Visit or be expected to require treatment during the treatment period of the study
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1 and during the treatment period.
  • Be a female who is pregnant, nursing, or planning a pregnancy at Visit 1. Be a woman of childbearing potential who is not using 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Ophthalmic and Vision Recearch

    New York, New York, 10022

Other trials in United States

About this study

Official title: Randomized, Controlled, Double-masked Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline) Nasal Spray on Objective and Subjective Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers

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
Being tested
OC-01 (varenicline 0.6mg/ml) Nasal Spray, Placebo (vehicle) nasal spray
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OC-01 (varenicline 0.6mg/ml) Nasal SprayDrug

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

  • Placebo (vehicle) nasal sprayDrug

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

Study groups in NCT05161208
Study groupRoleWhat they receive
OC-01 (varenicline 0.6mg/ml) nasal sprayExperimentalIntranasal delivery of OC-01 nasal spray twice daily (BID)
Receives: Drug: OC-01 (varenicline 0.6mg/ml) Nasal Spray
Placebo (vehicle) nasal sprayPlacebo comparatorIntranasal delivery of placebo vehicle nasal spray twice daily (BID)
Receives: Drug: Placebo (vehicle) nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CLDEQ-8 scores at 4 weeks

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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

Secondary outcomes (5)

  1. CLDEQ-8 scores at 8 weeks

    Mean change in CLDEQ-8 scores from baseline overtime through Week 8

    Measured: 8 weeks

  2. Contact lens wear time at 8 weeks

    Mean change in comfortable wear time, overall wear time, and utilization of artificial tears from baseline overtime through Week 8 as measured by virtual daily log

    Measured: 8 weeks

  3. Automated tear breakup time

    Mean change of automated tear film surface quality breakup time (TFSQ-BUT) over contact lenses from baseline overtime through week 8

    Measured: 8 weeks

  4. Tearscope tear breakup time

    Mean change in non-invasive tear break up time (NIBUT) from baseline overtime through week 8 as measure and rated by Tearscope Plus

    Measured: 8 weeks

  5. Vital staining score

    Mean change in vital staining overall score after lens removal from baseline overtime to week 8 as measured by masked evaluator

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start3 Dec 2021
  3. Primary completion25 Jul 2022
  4. Study completion25 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05161208
Sponsor's protocol ID
OP-001
Status last verified
Dec 2021
First submitted
30 Nov 2021
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OC-01 (varenicline 0.6mg/ml) Nasal Spray in people with Dry Eye, run by Center for Ophthalmic and Vision Research, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CLDEQ-8 scores at 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05161208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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Clinical Trial NCT05161208 | AzTrials