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Clinical Trial Summary

20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.

Clinical Trial Description

20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05184517
Study type Interventional
Source OphRx Ltd.
Contact David Zadok, Prof'
Phone 972-2-6666476
Email [email protected]
Status Not yet recruiting
Phase Early Phase 1
Start date March 2022
Completion date August 2022

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