drugset / Trial / NCT05660681
Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.
Timeline
- Start
- 2022-12-12
- Primary completion
- 2023-08-15
- Completion
- 2023-08-15
Publications
- Background Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
- Background Farrand KF, Fridman M, Stillman IO, Schaumberg DA. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. 2017 Oct;182:90-98. doi: 10.1016/j.ajo.2017.06.033. Epub 2017 Jul 10.
- Background Gensheimer WG, Kleinman DM, Gonzalez MO, Sobti D, Cooper ER, Smits G, Loxley A, Mitchnick M, Aquavella JV. Novel formulation of glycerin 1% artificial tears extends tear film break-up time compared with Systane lubricant eye drops. J Ocul Pharmacol Ther. 2012 Oct;28(5):473-8. doi: 10.1089/jop.2011.0053. Epub 2012 May 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycerin | Other / unclassified | 0.7 % | Topical |
| Subject | Polyethylene glycol 400 | Unknown | 0.3 % | Topical |
| Subject | Polyethylene glycol 400 | Unknown | 0.4 % | Topical |
| Comparator | Propylene Glycol | Small molecule | 0.3 % | Topical |