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

NCT05184517 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-05

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndromes

Interventions

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).

Sponsors & Collaborators

  • OphRx Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2023-07-06
Completion
2023-09-05
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184517 on ClinicalTrials.gov