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

NCT ID: NCT02965664

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-04-30

Brief Summary

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

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

PresbiDrops (CSF-1)

Intervention Type: DRUG

PresbiDrops (CSF-1) is a topical ophthalmic drug.

Placebo

Participants self-administer Placebo, with the supervision or help of the hospital staff - one drop in each eye on the day of treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients

Interventions

PresbiDrops (CSF-1)

PresbiDrops (CSF-1) is a topical ophthalmic drug.

Intervention Type: DRUG

Placebo

Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orasis Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Klienman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Director, Cataract Service, Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel

Zvi Segal, Dr.

Role: PRINCIPAL_INVESTIGATOR

Director of Ophthalmology Department, Western Galilee Medical Center, Nahariya, Israel

Locations

Ophthalmology Department, Western Galilee Medical Center

Nahariya, , Israel

The Department of Ophthalmology, Kaplan Medical Center

Rehovot, , Israel

Countries

Israel

Other Identifiers

FG-PRE-102

Identifier Type: -

Identifier Source: org_study_id