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

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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Drug: PresbiDrops (CSF-1); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 22100
    • Ophthalmology Department, Western Galilee Medical Center
  • Rehovot, Israel, 76100
    • The Department of Ophthalmology, Kaplan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PresbiDrops (CSF-1); 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); PresbiDrops (CSF-1) is a topical ophthalmic drug.
Placebo Comparator: Placebo; 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; Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Orasis Pharmaceuticals Ltd.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: FG-PRE-102