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

Primary Purpose

Dry Eye Syndromes

Status

Not yet recruiting

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Oph1

Restasis

About this trial

This is an interventional other trial for Dry Eye Syndromes

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Have chronic systemic disease of any form known.
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.
Be a user of topical ophthalmic products of any kind.
Being a chronic drug user.
Be a user of contact lenses.
Have a history of any type of eye surgery.
Participating in clinical research studies 90 days prior to inclusion in the present study.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm Description

Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation

Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation

Outcomes

Primary Outcome Measures

Drop Discomfort VAS score

Eye Discomfort VAS scale from 0-100

Secondary Outcome Measures

Drop Comfort VAS score

Eye Discomfort VAS scale from 0-100

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

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

Full Information

NCT ID

NCT05184517

First Posted

December 21, 2021

Last Updated

January 7, 2022

Sponsor

OphRx Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05184517

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OphRx Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Double blinded, participant and Outcome Assessors are blinded to the intervention

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation

Intervention Type

Drug

Intervention Name(s)

Oph1

Intervention Description

0.5% CsA ophthalmic formulation, twice daily for 4 days and once on the fifth day, one eye (right).

Intervention Type

Drug

Intervention Name(s)

Restasis

Intervention Description

0.05% CsA ophthalmic formulation twice daily for 4 days and once on the fifth day, one eye (right).

Primary Outcome Measure Information:

Title

Drop Discomfort VAS score

Description

Eye Discomfort VAS scale from 0-100

Time Frame

up to Fifth day per treatment (last dose for each treatment)

Secondary Outcome Measure Information:

Title

Drop Comfort VAS score

Description

Eye Discomfort VAS scale from 0-100

Time Frame

1-minute post-Dose. Fifth day per treatment (last dose for each treatment)

Title

Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.

Description

Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100

Time Frame

1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM

Title

Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale.

Description

Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100

Time Frame

5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 20-50 years, inclusive. Systemically and ophthalmologically healthy subjects evaluated during the clinical history. Best-corrected visual acuity (BCVA) 20/40 or better in both eyes. Negative Fluorescein staining in Fluorescein Corneal staining (FCS) in both eyes. Up to 0.5 Conjunctival redness in Conjunctival redness without slit lamp, in standardized lighting conditions, in both eyes. IOP (< 22mmHg), in both eyes. No pathology findings in Slit-lamp biomicroscopy in both eyes. Ability to comply with the requirements of the study and complete the questionnaire and a full sequence of protocol-related evaluations. Ability to understand and provide written informed consent. In the judgement of the investigator, the participant can safely perform study activity. Exclusion Criteria: Have chronic systemic disease of any form known. 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. Be a user of topical ophthalmic products of any kind. Being a chronic drug user. Be a user of contact lenses. Have a history of any type of eye surgery. Participating in clinical research studies 90 days prior to inclusion in the present study. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Zadok, Prof'

Phone

972-2-6666476

zadokd@szmc.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Yaniv Dolev, DVM

yaniv.dolev@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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