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A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PresbiDrops (CSF-1) | Experimental | 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 |
|
| Placebo | Placebo Comparator | Participants self-administer Placebo, with the supervision or help of the hospital staff - one drop in each eye on the day of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PresbiDrops (CSF-1) | Drug | PresbiDrops (CSF-1) is a topical ophthalmic drug. |
| |
| 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) |
| 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) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Klienman, Prof. | Director, Cataract Service, Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel | Principal Investigator |
| Zvi Segal, Dr. | Director of Ophthalmology Department, Western Galilee Medical Center, Nahariya, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Department, Western Galilee Medical Center | Nahariya | 22100 | Israel | |||
| The Department of Ophthalmology, Kaplan Medical Center |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016173 | Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Placebo |
| Drug |
Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients |
|
| Change from Baseline in pupil diameter and appearance | Baseline to end of treatment (up to 3 days) |
| Rehovot |
| 76100 |
| Israel |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |