PresbyopiaPhase 2NCT02965664
Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
A Phase 2 study testing PresbiDrops (CSF-1) in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 2 sites in Israel.
Trial summary
A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- PresbiDrops (CSF-1)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2016to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Ophthalmology Department, Western Galilee Medical Center
Nahariya, 22100
The Department of Ophthalmology, Kaplan Medical Center
Rehovot, 76100
About this study
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
A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects.
- Conditions
- Presbyopia
- Being tested
- PresbiDrops (CSF-1), Placebo
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PresbiDrops (CSF-1)Drug
PresbiDrops (CSF-1) is a topical ophthalmic drug.
PlaceboDrug
Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with ≥ 2 lines improvement from Baseline in best distance corrected near visual acuity (monocular and binocular)
Measured: Baseline to end of treatment (up to 3 days)
Secondary outcomes (3)
Change from Baseline in uncorrected near visual acuity (monocular and binocular)
Measured: Baseline to end of treatment (up to 3 days)
Change from Baseline in best corrected distance visual acuity (monocular and binocular)
Measured: Baseline to end of treatment (up to 3 days)
Change from Baseline in pupil diameter and appearance
Measured: Baseline to end of treatment (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orasis Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Klienman, Prof., Principal investigator, Director, Cataract Service, Ophthalmology Department, Kaplan Medical Center, Rehovot, IsraelZvi Segal, Dr., Principal investigator, Director of Ophthalmology Department, Western Galilee Medical Center, Nahariya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965664
- Sponsor's protocol ID
- FG-PRE-102
- Status last verified
- Jul 2017
- First submitted
- 14 Nov 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02965664
- Acronym / sponsor ID
- FG-PRE-102
- Conditions
- Presbyopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Orasis Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to Establish Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PresbiDrops (CSF-1) | Experimental | Drug: 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 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants self-administer Placebo, with the supervision or help of the hospital staff - one drop in each eye on the day of treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PresbiDrops (CSF-1)PresbiDrops (CSF-1) is a topical ophthalmic drug. | Drug | PresbiDrops (CSF-1) |
| PlaceboPlacebo drops contain the same ingredients as PresbiDrops except for the active ingredients | Drug | Placebo |
Primary outcome
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)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Klienman, Prof. principal investigator
Director, Cataract Service, Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel
Zvi Segal, Dr. principal investigator
Director of Ophthalmology Department, Western Galilee Medical Center, Nahariya, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PresbiDrops (CSF-1) in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.