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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02965664 |
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Date of registration:
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14/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
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Scientific 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 |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02965664 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Zvi Segal, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director of Ophthalmology Department, Western Galilee Medical Center, Nahariya, Israel |
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Name:
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Guy Klienman, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Director, Cataract Service, Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Men and women between 40 and 65 years of age (inclusive)
2. Subjects who provide written informed consent to participate in the study
3. Subjects have signs of presbyopia upon ophthalmic examination
4. 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)
5. 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
6. Subjects in general good health in the opinion of the Investigator as determined by
medical history
7. 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.
8. 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:
1. History of macular disease or any other ocular conditions or congenital malformation
2. Any medical condition known to affect the structure of uvea, cornea, lens or retina or
main function of the eyes
3. No cataract or minimal nuclear sclerosis
4. Severe dry eye
5. 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
6. Contact lenses for the past three months before the Screening visit
7. A difference of more than 0.50 Dioptres between the manifest spherical equivalent and
the objective refraction spherical equivalent
8. 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
9. A history of herpes (of any kind) in either eye
10. Cataract surgery and/or refractive surgery in either eye
11. Known contraindication, hypersensitivity and/or allergy to any study drugs or
excipients
12. Any acute illness (e.g. acute infection) within 48 hours of first study drug
administration, which is considered of significance by the Investigator
13. Participation in another clinical trial with drugs received within 30 days of
Screening
14. Pregnant or currently lactating women
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Presbyopia
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Intervention(s)
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Drug: PresbiDrops (CSF-1)
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Drug: Placebo
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Primary Outcome(s)
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Percentage of participants with = 2 lines improvement from Baseline in best distance corrected near visual acuity (monocular and binocular)
[Time Frame: Baseline to end of treatment (up to 3 days)]
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Secondary Outcome(s)
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Change from Baseline in best corrected distance visual acuity (monocular and binocular)
[Time Frame: Baseline to end of treatment (up to 3 days)]
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Change from Baseline in pupil diameter and appearance
[Time Frame: Baseline to end of treatment (up to 3 days)]
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Change from Baseline in uncorrected near visual acuity (monocular and binocular)
[Time Frame: Baseline to end of treatment (up to 3 days)]
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Secondary ID(s)
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FG-PRE-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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