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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Oph1; Drug: Restasis

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female aged 20-50 years, inclusive.
2. Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
3. Best-corrected visual acuity (BCVA) 20/40 or better in both eyes.
4. Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes.
5. Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes.
6. IOP (< 22mmHg), in both eyes.
7. No pathology findings in Slit-lamp biomicroscopy in both eyes.
8. Ability to comply with the requirements of the study and complete the questionnaire and a full sequence of protocol-related evaluations.
9. Ability to understand and provide written informed consent.
10. In the judgement of the investigator, the participant can safely perform study activity.

Exclusion Criteria:

1. Have chronic systemic disease of any form known.
2. In the case of women: be pregnant, breastfeeding or planning to become pregnant within the study period or women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
3. Be a user of topical ophthalmic products of any kind.
4. Being a chronic drug user.
5. Be a user of contact lenses.
6. Have a history of any type of eye surgery.
7. Participating in clinical research studies 90 days prior to inclusion in the present study.
8. In the judgement of the investigator, any condition that could interfere with the intent of the study or would make participation not in the best interest of the participant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation	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).
Experimental: Arm II; Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop Discomfort VAS score	Eye Discomfort VAS scale from 0-100	up to Fifth day per treatment (last dose for each treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop Comfort VAS score	Eye Discomfort VAS scale from 0-100	1-minute post-Dose. Fifth day per treatment (last dose for each treatment)
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.	Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100	1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.	Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100	5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM

Collaborators and Investigators

• Sponsor: OphRx Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: CD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes