Status:
COMPLETED
A Feasibility Study to Evaluate the Tolerability of Oph1 Compared to Restasis in Healthy Volunteers
Lead Sponsor:
OphRx Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20-50 years
Phase:
EARLY_PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05184517
Start Date
January 23 2023
End Date
September 5 2023
Last Update
April 5 2024
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102