PresbyopiaPhase 3NCT06045299
Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by Corxel Pharmaceuticals at 19 sites in China.
Trial summary
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Presbyopia, Near Vision, Miosis
- What is being tested?
- Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 19 sitesChina
- Study dates
- 27 Sep 2023to 27 Jan 2025
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder in both eyes determined by manifest refraction documented at Visit 1;
- Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
- Have +1.00 D to -4.00 D manifest refraction spherical equivalent（MRSE）of Spherical equivalent (SE) determined by manifest refraction documented at Visit 1.
- Be presbyopic as determined at Visit 2 baseline
Who cannot join
- Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications or their components;
- Have an active ocular infection at Visit 1 or at Visit 2 (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;
- Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
- Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Beijing Tongren Hospital, Capital Medical University
Beijing
Peking University First Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Ineye Hospital of Chengdu University of TCM
Chengdu
Dalian N0.3 people's hospital
Dalian
Guang Zhou Aier eye Hospital
Guangzhou
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou
The Affiliated Hospital of Guizhou Medical University
Guiyang
Affiliated Eye Hospital, Shandong University of Traditional Chinese Medicine
Jinan
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
Tongji Hospital Of Tongji University
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School Of Medicine
Shanghai
Shanxi Eye Hospital
Taiyuan
Tianjin Eye Hospital
Tianjin
Tianjin Medical University Eye Hospital
Tianjin
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang
Wuhan Aier Eye Hospital
Wuhan
Xi'An People's Hospital
Xi'an
Henan Eye Hospital & Henan Institute
Zhengzhou
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
Read the detailed description
A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.
- Conditions
- Presbyopia, Near Vision, Miosis, Eye Diseases
- Being tested
- Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, Placebo (Vehicle) ophthalmic solution
- Keywords
- Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic
- Medical subject headings
- Presbyopia, Myopia, Miosis, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aceclidine+Brimonidine combination ophthalmic solutionDrug
Also called LNZ101
Aceclidine+Brimonidine combination ophthalmic solution
Aceclidine ophthalmic solutionDrug
Also called LNZ100
Aceclidine ophthalmic solution
Placebo (Vehicle) ophthalmic solutionDrug
Placebo (Vehicle) ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| LNZ101 (Aceclidine/Brimonidine) ophthalmic solution | Experimental | Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. Receives: Drug: Aceclidine+Brimonidine combination ophthalmic solution |
| LNZ100 (Aceclidine) ophthalmic solution | Experimental | Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. Receives: Drug: Aceclidine ophthalmic solution |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Enrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. Receives: Drug: Placebo (Vehicle) ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected distance visual acuity (BCDVA) at 40 cm
Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m)
Measured: 3 hours post-treatment in the study eye at Visit 2 (Day 1）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Sep 2023
- Primary completion19 Aug 2024
- Study completion27 Jan 2025
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LENZ Therapeutics, Inc
- Responsible party
- Sponsor
- Investigators
- Gloria Sun, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045299
- Sponsor's protocol ID
- JX07001
- Other IDs
- CTR20232913
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
- ClinicalTrials.gov ID
- NCT06045299
- Acronym / sponsor ID
- JX07001
- Conditions
- Presbyopia, Near Vision, Miosis, Eye Diseases
- Keywords
- Presbyopia, Pharmaceutical Solutions, Opthalmic Solutions, Eye Drops, Miotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- LENZ Therapeutics, Inc
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- 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 Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase 3 Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Treatment of Presbyopia
Detailed description
A multicenter, randomized, double-masked, placebo-controlled efficacy and safety study . To evaluate the efficacy and safety of LNZ101 (Aceclidine 1.75%/Brimonidine 0.08%)/LNZ100 (Aceclidine 1.75%) compared with placebo for the treatment of presbyopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LNZ101 (Aceclidine/Brimonidine) ophthalmic solution | Experimental | Drug: Aceclidine+Brimonidine combination ophthalmic solutionEnrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. |
| LNZ100 (Aceclidine) ophthalmic solution | Experimental | Drug: Aceclidine ophthalmic solutionEnrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. |
| Placebo (Vehicle) ophthalmic solution | Placebo comparator | Drug: Placebo (Vehicle) ophthalmic solutionEnrolled subjects will be randomized to receive LNZ101, LNZ100, or placebo bilaterally once a day. Subjects will be instructed to dose 2 drops in both eyes (OU) (1 drop followed by 2 minutes later, another drop). Subjects will dose for 168 days. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be able and willing to provide written informed consent prior to any study procedure being performed;
- Be able and willing to follow all instructions and attend all study visits;
- Be 45-75 years of age of either sex at Visit 1;
- Have +1.00 to -4.00 diopter (D) of sphere calculated in minus cylinder in both eyes determined by manifest refraction documented at Visit 1;
- Have ≤2.00 D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
Key exclusion criteria (5 listed)
- Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy;
- Have known contraindications or sensitivity to the use of any of the study medications or their components;
- Have an active ocular infection at Visit 1 or at Visit 2 (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;
- Have moderate or severe dry eye at Visit 1, assessed by corneal fluorescein staining;
- Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity during dilated slitlamp biomicroscopy and fundus exam documented within 3 months of Visit 1 or at Visit 1;
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 |
|---|---|---|
| Aceclidine+Brimonidine combination ophthalmic solutionAlso: LNZ101Aceclidine+Brimonidine combination ophthalmic solution | Drug | LNZ101 (Aceclidine/Brimonidine) ophthalmic solution |
| Aceclidine ophthalmic solutionAlso: LNZ100Aceclidine ophthalmic solution | Drug | LNZ100 (Aceclidine) ophthalmic solution |
| Placebo (Vehicle) ophthalmic solutionPlacebo (Vehicle) ophthalmic solution | Drug | Placebo (Vehicle) ophthalmic solution |
Primary outcome
Best-corrected distance visual acuity (BCDVA) at 40 cm
Time frame: 3 hours post-treatment in the study eye at Visit 2 (Day 1）
Percentage of subjects who achieve a 3-line (15-letter) or greater improvement from baseline in the measurement of monocular BCDV at 40 cm and no loss in BCDVA ≥ 5 letters (ETDRS chart at 4 m)
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 3 Mar 2025.
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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.
Gloria Sun study director
Corxel Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aceclidine+Brimonidine combination ophthalmic solution and Aceclidine ophthalmic solution in people with Presbyopia and Near Vision, run by Corxel Pharmaceuticals at 19 sites in China.
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 7 inclusion and 5 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Best-corrected distance visual acuity (BCDVA) at 40 cm (time frame: 3 hours post-treatment in the study eye at Visit 2 (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 3 Mar 2025.