Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1), a Topical Ophthalmic Drug for Presbyopia

NCT ID: NCT02745223

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-06-30

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: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PresbiDrops (CSF-1)

Participants self-administered PresbiDrops (CSF-1), 1 drop in each eye each morning for 2 weeks.

Group Type: EXPERIMENTAL

PresbiDrops (CSF-1)

Intervention Type: DRUG

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

Placebo

Participants self-administered placebo, 1 drop in each eye each morning for 2 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo drops contains 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 contains 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 low distance refraction (sphere no greater than ±0.75 diopter cylinder no greater than ±0.75 diopter cylinder [DC], refraction along any principal meridian no greater than 1.00 diopter).

5. Subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is > +1.00 diopter.

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 they must be 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 (IUD), 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 the 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 the Screening visit.

6. Contact lenses for the past three months before the Screening visit.

7. A difference of more than 0.50 diopter between the manifest spherical equivalent and the wave front 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 (eg, 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

Eytan Blumental

Role: STUDY_DIRECTOR

Head of Ophthalmology Department, Rambam Medical Center, Haifa, Israel

Andreja Veselica

Role: STUDY_DIRECTOR

VID Medical Center, Nova Gorica, Slovenia

Locations

The Department of Ophthalmology, Rambam Health Care Campus

Haifa, , Israel

Countries

Israel

Other Identifiers

FG-PRE-101

Identifier Type: -

Identifier Source: org_study_id