Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects

Study Overview
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Brief Summary
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A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects.

Official Title
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A Phase 2a, Double-Masked, Randomized, Placebo-Controlled, Single-Administration Study to Establish Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: PresbiDrops (CSF-1)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between 40 and 65 years of age (inclusive) Subjects who provide written informed consent to participate in the study Subjects have signs of presbyopia upon ophthalmic examination Subjects have normal presbyopia with no distance correction or with distance refraction, which is within those limits: sphere between +3 Dioptres and -3 Dioptres, cylinder no greater than ± 0.75 DC (based on subjective refraction test) Subjects must have best corrected vision of at least 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is > +1.00 Dioptres Subjects in general good health in the opinion of the Investigator as determined by medical history Women with childbearing potential must have a negative urine pregnancy test at Screening and be willing and able to use a medically acceptable method of birth control or postmenopausal. Acceptable methods of birth control in this study include: vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device, hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study Exclusion Criteria: History of macular disease or any other ocular conditions or congenital malformation Any medical condition known to affect the structure of uvea, cornea, lens or retina or main function of the eyes No cataract or minimal nuclear sclerosis Severe dry eye Any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before Screening Contact lenses for the past three months before the Screening visit A difference of more than 0.50 Dioptres between the manifest spherical equivalent and the objective refraction spherical equivalent Pupil size less than 2.5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the Baseline visit A history of herpes (of any kind) in either eye Cataract surgery and/or refractive surgery in either eye Known contraindication, hypersensitivity and/or allergy to any study drugs or excipients Any acute illness (e.g. acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator Participation in another clinical trial with drugs received within 30 days of Screening Pregnant or currently lactating women

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PresbiDrops (CSF-1)<br>Participants self-administer PresbiDrops (CSF-1) , with the supervision or help of the hospital staff - one drop in each eye on the day of treatment | Drug: PresbiDrops (CSF-1)<br>* PresbiDrops (CSF-1) is a topical ophthalmic drug.<br>|
| Placebo Comparator: Placebo<br>Participants self-administer Placebo, with the supervision or help of the hospital staff - one drop in each eye on the day of treatment | Drug: Placebo<br>* Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with ≥ 2 lines improvement from Baseline in best distance corrected near visual acuity (monocular and binocular) |  | Baseline to end of treatment (up to 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in uncorrected near visual acuity (monocular and binocular) |  | Baseline to end of treatment (up to 3 days) | 
| Change from Baseline in best corrected distance visual acuity (monocular and binocular) |  | Baseline to end of treatment (up to 3 days) | 
| Change from Baseline in pupil diameter and appearance |  | Baseline to end of treatment (up to 3 days) |