PresbyopiaPhase 2NCT02745223
Safety, Tolerability, and Efficacy of PresbiDrops (CSF-1), a Topical Ophthalmic Drug for Presbyopia
A Phase 2 study testing PresbiDrops (CSF-1) in people with Presbyopia, run by Orasis Pharmaceuticals Ltd. at 1 site 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
- 1 siteIsrael
- Study dates
- Jul 2016to Jun 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 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).
- 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.
- 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 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.
- 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 the 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 the Screening visit.
- Contact lenses for the past three months before the Screening visit.
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- A difference of more than 0.50 diopter between the manifest spherical equivalent and the wave front 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 (eg, 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
1 site in 1 country.
About this study
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
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 contains the same ingredients as PresbiDrops except for the active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| PresbiDrops (CSF-1) | Experimental | Participants self-administered PresbiDrops (CSF-1), 1 drop in each eye each morning for 2 weeks. Receives: Drug: PresbiDrops (CSF-1) |
| Placebo | Placebo comparator | Participants self-administered placebo, 1 drop in each eye each morning for 2 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity
Uncorrected visual acuity will be assessed at distance and near (40 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance visual acuity will be measured under normal light conditions. Near acuity will be measured both in poor light conditions and normal light conditions.
Measured: Baseline to end of treatment (up to 14 days)
Mean change from Baseline in the number of lines correctly identified in uncorrected near distance visual acuity
Uncorrected visual acuity will be assessed at distance and near (40 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance visual acuity will be measured under normal light conditions. Near acuity will be measured both in poor light conditions.
Measured: Baseline to end of treatment (up to 14 days)
Secondary outcomes (8)
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected intermediate distance visual acuity
Uncorrected visual acuity will be assessed at distance and intermediate (60 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance and intermediate visual acuity will be measured under normal light conditions.
Measured: Baseline to end of treatment (up to 14 days)
Mean change from Baseline in the number of lines correctly identified in uncorrected intermediate distance visual acuity
Uncorrected visual acuity will be assessed at distance and intermediate (60 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance and intermediate visual acuity will be measured under normal light conditions.
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in the depth of focus at distance and near
Depth of focus (DoF) is defined as the distance in diopters that a viewed object can be moved towards or away from the eye until the object is no longer judged to be in focus. DoF will be assessed using either wavefront aberrometry or according to the following instructions. Distance: Set the distance spectacle prescription in the refractor head/trial frame. Have the participant look at the 6/9 (0.6) Snellen letter. Increase the plus sphere power until the participant reports blurring (+a diopters). Repeat using negative lenses (-b diopters). Remove the negative sign in front of b. Depth of focus at distance = (a+b) diopters. Near: Set the distance spectacle prescription at +2.5 diopters in the refractor head/trial frame. Have the participant look at the J2 print at 40 cm. Increase the plus sphere power until the participant reports blurring (+x diopters). Repeat using negative lenses (-y diopters). Remove the negative sign in front of y. The depth of focus at near = (x+y) diopters.
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in uncorrected distance visual acuity
Uncorrected visual acuity will be assessed at distance using a standardized eye chart under normal light conditions. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested.
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in the need for glasses
The Patient Reported Outcome Questionnaire includes 29 questions assessing subject satisfaction of their vision and the need for eye glasses in order to perform daily tasks.
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in pupil diameter and appearance
Pupil size and appearance will be evaluated by wave-front aberrometer. Examination will be conducted at near mesopic conditions, in low but not quite dark lighting situations at a fixed setting on the light meter. Mesopic light levels range from luminance of approximately 0.001 to 3 cd m-2, an appropriate and fixed setting will be selected, that reflects most night-time outdoor and traffic lighting scenarios. An examination of pupillary function includes inspecting the pupils for equal size (1 mm or less of difference may be normal), regular shape, reactivity to light, and direct and consensual accommodation (PERRLA [D+C]; Pupils Equal and Round, Reactive to Light and Accommodation [Direct and Consensual]).
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in the stability of pre-corneal tear film
Assessment of the stability of pre-corneal tear film will be conducted using non-invasive break up time (NIBUT) and tear meniscus height. NIBUT is measured with instruments such as a Keratometer, a hand-held Keratoscope, or a Tearscope. After a blink, the reflection observed with these instruments is clear and crisp when the ocular surface is free from any irregularities. NIBUT is defined as the interval between the opening of the eyes and the moment when an irregularity is observed. NIBUT values < 10 seconds indicate dry eyes. Tear meniscus height (TMH) can be measured with a slit-lamp biomicroscope. A slit lamp image of the lower TMH can be photographed or captured electronically and later measured directly on screen and corrected for magnification. The lower TMH represents the total volume of tears at the ocular surface. Heights of less than 0.2 mm indicate reduced tear volume. A tear meniscus with a scalloped edge is often associated with a dry eye.
Measured: Baseline to end of treatment (up to 14 days)
Change from Baseline in visual field
Testing the visual fields will consist of confrontation field testing in which each eye is tested separately to assess the extent of the peripheral field. Visual field is assessed in each eye separately. The participant occludes 1 eye while fixated on the examiner's eye with the non-occluded eye. The subject is then asked to count the number of fingers that are briefly flashed in each of 4 quadrants (left, right, up, and down).
Measured: Baseline to end of treatment (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completionJun 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
- Crossover
- 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
- Eytan Blumental, Study director, Head of Ophthalmology Department, Rambam Medical Center, Haifa, IsraelAndreja Veselica, Study director, VID Medical Center, Nova Gorica, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745223
- Sponsor's protocol ID
- FG-PRE-101
- Status last verified
- Jul 2017
- First submitted
- 9 Mar 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-blind, Randomized, Placebo-controlled, Repeated Administration, Crossover Study to Establish Safety, Tolerability and Efficacy of PresbiDrops (CSF-1) in Presbyopic Subjects
- ClinicalTrials.gov ID
- NCT02745223
- Acronym / sponsor ID
- FG-PRE-101
- 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
- Jul 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Apr 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
- Crossover
- 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-administered PresbiDrops (CSF-1), 1 drop in each eye each morning for 2 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants self-administered placebo, 1 drop in each eye each morning for 2 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 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).
- 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.
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 the 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 the Screening visit.
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 contains the same ingredients as PresbiDrops except for the active ingredients. | Drug | Placebo |
Primary outcome
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity
Time frame: Baseline to end of treatment (up to 14 days)
Uncorrected visual acuity will be assessed at distance and near (40 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance visual acuity will be measured under normal light conditions. Near acuity will be measured both in poor light conditions and normal light conditions.
Mean change from Baseline in the number of lines correctly identified in uncorrected near distance visual acuity
Time frame: Baseline to end of treatment (up to 14 days)
Uncorrected visual acuity will be assessed at distance and near (40 cm) using a standardized eye chart. The number of lines in the eye chart that the participant correctly identifies will be measured. The test will be performed both binocularly and on 1 eye at a time by covering the eye not being tested. Distance visual acuity will be measured under normal light conditions. Near acuity will be measured both in poor light conditions.
8 secondary outcomes
Percentage of participants with a ≥ 2 line improvement from Baseline in uncorrected intermediate distance visual acuity
Time frame: Baseline to end of treatment (up to 14 days)
Mean change from Baseline in the number of lines correctly identified in uncorrected intermediate distance visual acuity
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in the depth of focus at distance and near
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in uncorrected distance visual acuity
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in the need for glasses
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in pupil diameter and appearance
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in the stability of pre-corneal tear film
Time frame: Baseline to end of treatment (up to 14 days)
Change from Baseline in visual field
Time frame: Baseline to end of treatment (up to 14 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.
Eytan Blumental study director
Head of Ophthalmology Department, Rambam Medical Center, Haifa, Israel
Andreja Veselica study director
VID Medical Center, Nova Gorica, Slovenia
1 site 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 1 site 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 8 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 1 site 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 a ≥ 2 line improvement from Baseline in uncorrected near distance visual acuity (time frame: Baseline to end of treatment (up to 14 days)). The study lists 2 primary outcomes in all. 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.