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

NCT02965664 | Completed Phase 2 DMC

• 1 other identifier: FG-PRE-102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

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

Drug: PresbiDrops (CSF-1)

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

Drug: Placebo

Interventions

PresbiDrops (CSF-1) DRUG

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

PresbiDrops (CSF-1)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of macular disease or any other ocular conditions or congenital malformation
• Any medical condition known to affect the structure of uvea, cornea, lens or retina or main function of the eyes
• No cataract or minimal nuclear sclerosis
• Severe dry eye
• 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
• Contact lenses for the past three months before the Screening visit
• A difference of more than 0.50 Dioptres between the manifest spherical equivalent and the objective refraction spherical equivalent
• 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
• A history of herpes (of any kind) in either eye
• Cataract surgery and/or refractive surgery in either eye
• Known contraindication, hypersensitivity and/or allergy to any study drugs or excipients
• Any acute illness (e.g. acute infection) within 48 hours of first study drug administration, which is considered of significance by the Investigator
• Participation in another clinical trial with drugs received within 30 days of Screening
• Pregnant or currently lactating women

Sponsors & Collaborators

• Orasis Pharmaceuticals Ltd.: lead

Study Sites (2)

Ophthalmology Department, Western Galilee Medical Center

Nahariya, 22100, Israel

Location

The Department of Ophthalmology, Kaplan Medical Center

Rehovot, 76100, Israel

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 17, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

IL (2)