drugset / Trial / NCT06478134
Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.
Timeline
- Start
- 2023-07-01
- Primary completion
- 2024-01-10
- Completion
- 2024-05-01
Publications
- Background Vigo L, Senni C, Pellegrini M, Vagge A, Ferro Desideri L, Carones F, Scorcia V, Giannaccare G. Effects of a New Formulation of Multiple-Action Tear Substitute on Objective Ocular Surface Parameters and Ocular Discomfort Symptoms in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1441-1447. doi: 10.1007/s40123-022-00518-7. Epub 2022 May 14.
- Background Roszkowska AM, Inferrera L, Spinella R, Postorino EI, Gargano R, Oliverio GW, Aragona P. Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye. J Clin Med. 2022 Nov 26;11(23):6975. doi: 10.3390/jcm11236975.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hyaluronic Acid | Other / unclassified | 0.15 % | Other |
| Subject | TriMix | Messenger RNA (mRNA) | 0.15 % | Other |
| Subject | TriMix | Messenger RNA (mRNA) | 0.25 % | Other |
| Subject | TriMix | Messenger RNA (mRNA) | 1 % | Other |
| Subject | TriMix | Messenger RNA (mRNA) | 3 % | Other |