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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC-01 (varenicline 0.6mg/ml) nasal spray | Experimental | Intranasal delivery of OC-01 nasal spray twice daily (BID) |
|
| Placebo (vehicle) nasal spray | Placebo Comparator | Intranasal delivery of placebo vehicle nasal spray twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC-01 (varenicline 0.6mg/ml) Nasal Spray | Drug | Intranasal delivery of OC-01 nasal spray twice daily (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CLDEQ-8 scores at 8 weeks | Mean change in CLDEQ-8 scores from baseline overtime through Week 8 | 8 weeks |
| 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 |
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Inclusion Criteria:
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).
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Ophthalmic and Vision Recearch | New York | New York | 10022 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo (vehicle) nasal spray | Drug | Intranasal delivery of Placebo (vehicle) nasal spray twice daily (BID) |
|
| 8 weeks |
| 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 | 8 weeks |
| 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 | 8 weeks |
| Vital staining score | Mean change in vital staining overall score after lens removal from baseline overtime to week 8 as measured by masked evaluator | 8 weeks |
| D011810 | Quinoxalines |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |