Clinical trial NCT02745223: Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1), a Topical Ophthalmic Drug for Presbyopia
Official title: A Phase 2a, Double-blind, Randomized, Placebo-controlled, Repeated Administration, Crossover Study to Establish Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Orasis Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to establish safety, tolerability, and efficacy of PresbiDrops (CSF-1) in presbyopic subjects.


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.

Primary outcomes:
measure: Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Mean change from Baseline in the number of lines correctly identified in uncorrected near distance visual acuity
timeFrame: Baseline to end of treatment (up to 14 days)
Secondary outcomes:
measure: Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected intermediate distance visual acuity
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Mean change from Baseline in the number of lines correctly identified in uncorrected intermediate distance visual acuity
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in the depth of focus at distance and near
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in uncorrected distance visual acuity
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in the need for glasses
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in pupil diameter and appearance
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in the stability of pre-corneal tear film
timeFrame: Baseline to end of treatment (up to 14 days)
measure: Change from Baseline in visual field
timeFrame: Baseline to end of treatment (up to 14 days)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: The Department of Ophthalmology, Rambam Health Care Campus
Study officials:
affiliation: Head of Ophthalmology Department, Rambam Medical Center, Haifa, Israel
name: Eytan Blumental
role: STUDY_DIRECTOR
affiliation: VID Medical Center, Nova Gorica, Slovenia
name: Andreja Veselica
role: STUDY_DIRECTOR
References: