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Trial record 3 of 5 for:    orasis presbyopia

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.
 
ClinicalTrials.gov Identifier: NCT02965664
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Orasis Pharmaceuticals Ltd.

Tracking Information
First Submitted Date  ICMJE November 14, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Change from Baseline in uncorrected near visual acuity (monocular and binocular) [ Time Frame: Baseline to end of treatment (up to 3 days) ]
  • Change from Baseline in best corrected distance visual acuity (monocular and binocular) [ Time Frame: Baseline to end of treatment (up to 3 days) ]
  • Change from Baseline in pupil diameter and appearance [ Time Frame: Baseline to end of treatment (up to 3 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
Official Title  ICMJE A Phase 2a, Double-Masked, Randomized, Placebo-Controlled, Single-Administration Study to Establish Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
Brief Summary A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE
  • Drug: PresbiDrops (CSF-1)
    PresbiDrops (CSF-1) is a topical ophthalmic drug.
  • Drug: Placebo
    Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients
Study Arms  ICMJE
  • 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
    Intervention: Drug: PresbiDrops (CSF-1)
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2017)
36
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
50
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965664
Other Study ID Numbers  ICMJE FG-PRE-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orasis Pharmaceuticals Ltd.
Study Sponsor  ICMJE Orasis Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Orasis Pharmaceuticals Ltd.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP