NCT05184517

A Feasibility Study to Evaluate the Tolerability of Oph1 Compared to Restasis in Healthy Volunteers

A Feasibility, Double Blind, Randomized, Crossover Study to Evaluate the Tolerability of Oph1 0.5% Cyclosporine Ophthalmic Formulation Compared to Restasis in Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: OphRx Ltd. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Oph1	0.5% CsA ophthalmic formulation, twice daily for 4 days and once on the fifth day, one eye (right).
DRUG	Restasis	0.05% CsA ophthalmic formulation twice daily for 4 days and once on the fifth day, one eye (right).

Timeline

• Start date: 2023-01-23
• Primary completion: 2023-07-06
• Completion: 2023-09-05
• First posted: 2022-01-11
• Last updated: 2024-04-05

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study