PresbyopiaPhase 2NCT02554396
Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
A Phase 2 study testing PRX-100 in people with Presbyopia, run by LENZ Therapeutics, Inc at 1 site in United States.
Trial summary
This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1, PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects on improving near-vision acuity. Read more about this study
- Who is it for?
- Ages 45 to 59 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- PRX-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 2015
- 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 45 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be 45-59 years of age of either sex and any race or ethnicity;
- be able and willing to provide written informed consent and sign HIPAA form prior to any study procedure being performed;
- be able and willing to follow all instructions and attend all study visits;
- have a negative urine pregnancy test at Visit 1, if female of childbearing potential (those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control throughout the study period. Adequate birth control is defined as hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control;
- be an early to moderate presbyope
- be able and willing to avoid all disallowed medication(s) for the appropriate washout period and during the study without significant risk to the subject (see exclusion 15).
Who cannot join
- have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
- have an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye. Mild dry eye controlled with artificial tears and mild blepharitis controlled with lid scrubs is allowed;
- have had surgical intervention (ocular or systemic) within 6 months prior to Visit 1, or planned surgical intervention within 30 days thereafter;
- have had refractive surgery in the past;
- have dry eye history defined as either current use of Restasis®, past history of insertion of punctual plugs, or daily use of artificial tears more than one drop per day;
- have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
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- have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg, or be on any type of intraocular hypertension or any type of glaucoma topical treatment at Visit 1;
- have red-green color blindness confirmed by Ishihara test during baseline procedures;
- have an inability or refuse to discontinue contact lens wear 7 days prior to the study visit and during the study visit;
- have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study;
- be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy; tests positive to a urine pregnancy test at Visit 1; or refuses to use an adequate method of contraception for the duration of the study;
- have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
- use any of the following disallowed medications during the 2 weeks (14 days) prior to Visit 1 and during the study:
- narcotic (opiate class) pain medication (e.g. codeine, oxycontin, Vicodin®, Tramadol®)
- bladder medication (e.g. urecholine, bethanechol®)
- antipsychotics
- antidepressants
- anticholinergics (e.g. atropine, belladonna, benztropine, dicyclomine, donepezil, hyoscyamine, propantheline, scopolamine, trihexphenidyl
- dry mouth (e.g. salagen®), Evoxac®)
- antihistamines or decongestants
- artificial tear use of more than 1 drop per day
- diagnostic medications required by the protocol are allowed;
- report of recreational drug use (e.g. marijuana, methadone, heroin, cocaine).
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 (Aceclidine/Tropicamide) Ophthalmic Topical Formulation in the Treatment of Early to Moderate Presbyopia
This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1, PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects on improving near-vision acuity.
- Conditions
- Presbyopia
- Being tested
- PRX-100, Placebo
- Keywords
- ophthalmology, vision, ocular
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-100Drug
ophthalmic solution
PlaceboDrug
saline ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| PRX-100 | Experimental | PRX-100 ophthalmic solution Receives: Drug: PRX-100 |
| Placebo | Placebo comparator | saline solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
binocular assessment of uncorrected near visual acuity
Measured: day 1
Secondary outcomes (1)
pupil diameter
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LENZ Therapeutics, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554396
- Sponsor's protocol ID
- PRX100.FDAII
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2015
- Last updated
- 23 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Masked Evaluation of the Efficacy and Safety of PRX-100 (Aceclidine/Tropicamide) Ophthalmic Topical Formulation in the Treatment of Early to Moderate Presbyopia
- ClinicalTrials.gov ID
- NCT02554396
- Acronym / sponsor ID
- PRX100.FDAII
- Conditions
- Presbyopia
- Keywords
- ophthalmology, vision, ocular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LENZ Therapeutics, IncUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Sep 2015 (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.
This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1, PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects on improving near-vision acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX-100 | Experimental | Drug: PRX-100PRX-100 ophthalmic solution |
| Placebo | Placebo comparator | Drug: Placebosaline solution |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- be 45-59 years of age of either sex and any race or ethnicity;
- be able and willing to provide written informed consent and sign HIPAA form prior to any study procedure being performed;
- be able and willing to follow all instructions and attend all study visits;
- have a negative urine pregnancy test at Visit 1, if female of childbearing potential (those who have experienced menarche and who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control throughout the study period. Adequate birth control is defined as hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control;
- be an early to moderate presbyope
Key exclusion criteria (23 listed)
- have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
- have an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye. Mild dry eye controlled with artificial tears and mild blepharitis controlled with lid scrubs is allowed;
- have had surgical intervention (ocular or systemic) within 6 months prior to Visit 1, or planned surgical intervention within 30 days thereafter;
- have had refractive surgery in the past;
- have dry eye history defined as either current use of Restasis®, past history of insertion of punctual plugs, or daily use of artificial tears more than one drop per day;
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 |
|---|---|---|
| PRX-100ophthalmic solution | Drug | PRX-100 |
| Placebosaline ophthalmic solution | Drug | Placebo |
Primary outcome
binocular assessment of uncorrected near visual acuity
Time frame: day 1
1 secondary outcome
pupil diameter
Time frame: day 1
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 23 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 PRX-100 in people with Presbyopia, run by LENZ Therapeutics, Inc at 1 site in United States.
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 6 inclusion and 23 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 23 Oct 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 United States. 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?
binocular assessment of uncorrected near visual acuity (time frame: day 1). 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 23 Oct 2017.