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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02965664
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.

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

Condition or disease Intervention/treatment Phase
Presbyopia Drug: PresbiDrops (CSF-1) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Double-Masked, Randomized, Placebo-Controlled, Single-Administration Study to Establish Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
Actual Study Start Date : December 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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

Primary Outcome Measures :
  1. Percentage of participants with ≥ 2 lines improvement from Baseline in best distance corrected near visual acuity (monocular and binocular) [ Time Frame: Baseline to end of treatment (up to 3 days) ]

Secondary Outcome Measures :
  1. Change from Baseline in uncorrected near visual acuity (monocular and binocular) [ Time Frame: Baseline to end of treatment (up to 3 days) ]
  2. Change from Baseline in best corrected distance visual acuity (monocular and binocular) [ Time Frame: Baseline to end of treatment (up to 3 days) ]
  3. Change from Baseline in pupil diameter and appearance [ Time Frame: Baseline to end of treatment (up to 3 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02965664

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Ophthalmology Department, Western Galilee Medical Center
Nahariya, Israel, 22100
The Department of Ophthalmology, Kaplan Medical Center
Rehovot, Israel, 76100
Sponsors and Collaborators
Orasis Pharmaceuticals Ltd.
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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
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Responsible Party: Orasis Pharmaceuticals Ltd. Identifier: NCT02965664    
Other Study ID Numbers: FG-PRE-102
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases