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

NCT05184517 | Completed Early Phase 1 FDA Drug

• 1 other identifier: CD-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Drop Discomfort VAS score

  Eye Discomfort VAS scale from 0-100

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

Secondary Outcomes (3)

• Drop Comfort VAS score

  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.

  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.

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

Study Arms (2)

Arm I

EXPERIMENTAL

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

Drug: Oph1; Drug: Restasis

Arm II

EXPERIMENTAL

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

Drug: Oph1; Drug: Restasis

Interventions

Oph1 DRUG

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

Arm I; Arm II

Restasis DRUG

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

Arm I; Arm II

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• OphRx Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded, participant and Outcome Assessors are blinded to the intervention
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: January 23, 2023
• Primary Completion: July 6, 2023
• Study Completion: September 5, 2023
• Last Updated: April 5, 2024

Record last verified: 2021-12

Locations

IL (1)