Dry Eye Disease
Conditions
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.
Detailed description
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.
Interventions
DRUGVarenicline solution
OC-01 nasal spray 0.03 mg
DRUGPlacebo nasal spray (OC-01 Vehicle Nasal Spray)
Placebo nasal spray (OC-01 Vehicle Nasal Spray)
Sponsors
Stephenson Eye Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Subjects must not: 1. Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit 2. Have evidence of clinically significant ocular trauma 3. Have active ocular Herpes simplex or Herpes Zoster infection 4. Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator 5. Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum) 6. Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) 7. Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) 8. 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) 9. 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.) 10. 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 11. Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas 12. Have any untreated nasal infection at Visit 1 13. Have a history of vascularized nasal polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction 14. 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. 15. Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit 16. Use topical prescription ophthalmic medications including cyclosporine and/or lifitegrast within 6 months prior to the Screening/Baseline Visit and during the treatment period 17. Use topical ophthalmic corticosteroid therapy within 6 weeks prior to the Screening/Baseline visit and during the treatment period 18. Use ophthalmic artificial tear drops within 2 hours prior to any of the study visits; any concurrent use of artificial tears should be continued at same frequency and with no change in brand during the treatment period 19. Use prescription or Over-the-counter (OTC) topical ophthalmic mast cell stabilizers or antihistamines within 3 days of the Screening/Baseline visit and during the treatment period (systemic agents permitted) 20. Have a known hypersensitivity to any of the procedural agents or study drug components 21. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening/Baseline visit and during the treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface qualifier image change | Day 1 | Change from baseline in Cassini surface qualifier image analysis to post-administration of OC-01 (varenicline solution) nasal spray (@15 minutes) on Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye Dryness Score (EDS) | Day 28 | Mean change from baseline in symptom score (EDS) The questionnaire used a 0-100 Visual Analog Scale (VAS), with 0 indicating no discomfort and 100 indicating maximal discomfort. |
| Change from baseline in surface qualifier image analysis | Day 28 | Change from baseline in surface qualifier image analysis to pre-administration of varenicline solution nasal spray |
| Fluorescein staining score | Day 28 | Mean change from baseline in fluorescein staining score |
| Tear Break-up Time (TBUT) | Day 28 | Mean change from baseline in fluorescein tear breakup time (TBUT) |
| Dry Eye-Related Quality of Life Score (DEQS) questionnaire | Day 21 | Mean change in the Dry Eye-Related Quality of Life Score (DEQS) from baseline. The questionnaire included 15 questions - 6 about bothersome ocular symptoms and 9 on the impact of DED on daily life. A quality-of-life score ranging from 0 (no disability) to 100 (maximum disability) was calculated. |
| Visual Acuity (VA) | Day 28 | Mean change from baseline in visual acuity (logMAR) |
| Intraocular Pressure (IOP) | Day 28 | Mean change from baseline in intraocular pressure |
Countries
United States
Outcome results
None listed