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

April 3, 2024 updated by: OphRx Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drop Discomfort VAS score
Time Frame: up to Fifth day per treatment (last dose for each treatment)
Eye Discomfort VAS scale from 0-100
up to Fifth day per treatment (last dose for each treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drop Comfort VAS score
Time Frame: 1-minute post-Dose. Fifth day per treatment (last dose for each treatment)
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.
Time Frame: 1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
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.
Time Frame: 5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OphRx Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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