Evaluation of Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

NCT05514041 | Completed Phase 4 FDA Drug

• 1 other identifier: 2022-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Surface qualifier image change

  Change from baseline in Cassini surface qualifier image analysis to post-administration of OC-01 (varenicline solution) nasal spray (@15 minutes) on Day 1

  Day 1

Secondary Outcomes (7)

• Eye Dryness Score (EDS)

  Day 28

• Change from baseline in surface qualifier image analysis

  Day 28

• Fluorescein staining score

  Day 28

• Tear Break-up Time (TBUT)

  Day 28

• Dry Eye-Related Quality of Life Score (DEQS) questionnaire

  Day 21

Other Outcomes (1)

• Adverse Events (AEs)

  28 days

Study Arms (2)

OC-01 (varenicline solution) nasal spray 0.03 mg

EXPERIMENTAL

Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations

Drug: Varenicline solution

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

PLACEBO COMPARATOR

Subjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations

Drug: Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Interventions

Varenicline solution DRUG

OC-01 nasal spray 0.03 mg

OC-01 (varenicline solution) nasal spray 0.03 mg

Placebo nasal spray (OC-01 Vehicle Nasal Spray) DRUG

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must:
• Provide signed written consent prior to study-related procedures
• Be at least 22 years of age at the screening visit
• 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
• Have an Ocular surface disease index (OSDI) score ≥13,
• Demonstrate corneal fluorescein staining (CFS) score of 2 or more in at least 1 corneal region, or a sum of 4 or more for all corneal regions, based on the National Eye Institute/Industry Workshop Scale
• Demonstrate abnormal Cassini surface qualifier image at screening visit (at the determination of the investigator)

You may not qualify if:

• Subjects must not:
• Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
• Have evidence of clinically significant ocular trauma
• Have active ocular Herpes simplex or Herpes Zoster infection
• Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
• Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
• Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
• Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal 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 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 any untreated nasal infection at Visit 1
• Have a history of vascularized nasal 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.

Sponsors & Collaborators

• Stephenson Eye Associates: lead

Study Sites (1)

Stephenson Eye Associates

Venice, Florida, 34285, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Change in Cassini surface qualifier image analysis from baseline (pre-administration) to post-administration of OC-01 (varenicline solution) nasal spray as measured by a masked evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: October 11, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)