PresbyopiaPhase 3NCT06451666
Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia
A Phase 3 study testing Pilocarpine HCl Ophthalmic Solution in people with Presbyopia, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Pilocarpine HCl Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Dec 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
- 2 Emmetropes or non-emmetropes with best distance correction in the range of spherical -4.00 D to +2.00 D inclusively and cylinder ±2.00 D with photopic, high contrast CDVA of 20/25 or better in each eye at the screening and baseline visits;
- 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
- 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
- 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
- 6 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;
- 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;
- 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;
- 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;
- 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;
- 6 History of cataract surgery, phakic intraocular lens surgery, corneal refractive surgery, radial keratotomy, or any intraocular surgery;
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- 7 Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters;
- 8 Moderate to severe dry eye disease at the screening visit;
- 9 Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis at the screening visit;
- 10 Diagnosis of any type of glaucoma or ocular hypertension;
- 11 Female who have a positive pregnancy test during the screening period, lactating, or planning a pregnancy during the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia
A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia.
- Conditions
- Presbyopia
- Being tested
- Pilocarpine HCl Ophthalmic Solution, Vehicle
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine HCl Ophthalmic SolutionDrug
Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days
VehicleDrug
Vehicle, one drop in each eye, once daily, for up to 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine HCl Ophthalmic Solution | Experimental | Not described Receives: Drug: Pilocarpine HCl Ophthalmic Solution |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Measured: Baseline (Day 1) to Day 30 (Hour 3)
Secondary outcomes (8)
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.
Measured: Through study completion, an average of 60 days
Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)
Measured: Day 1 and Day 30
Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)
Measured: Day 1 and Day 30
Maximum plasma concentration(Cmax)
Measured: Day 1 and Day 30
Time to maximum plasma concentration (Tmax)
Measured: Day 1 and Day 30
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Measured: Day 1 and Day 30
Apparent Terminal Elimination Half-Life (T1/2)
Measured: Day 1 and Day 30
Apparent total body clearance (CL/F)
Measured: Day 1 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- For arm 1, patients received pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. For arm 2, patients received vehicle, one drop in each eye, once daily, for up to 30 days.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451666
- Sponsor's protocol ID
- SYH9042-001
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 3 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia
- ClinicalTrials.gov ID
- NCT06451666
- Acronym / sponsor ID
- SYH9042-001
- Conditions
- Presbyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 11 Jun 2024 (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 study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For arm 1, patients received pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days. For arm 2, patients received vehicle, one drop in each eye, once daily, for up to 30 days.
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine HCl Ophthalmic Solution | Experimental | Drug: Pilocarpine HCl Ophthalmic Solution |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
- 2 Emmetropes or non-emmetropes with best distance correction in the range of spherical -4.00 D to +2.00 D inclusively and cylinder ±2.00 D with photopic, high contrast CDVA of 20/25 or better in each eye at the screening and baseline visits;
- 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
- 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
- 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
Key exclusion criteria (11 listed)
- 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;
- 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;
- 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;
- 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;
- 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;
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 |
|---|---|---|
| Pilocarpine HCl Ophthalmic SolutionPilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days | Drug | Pilocarpine HCl Ophthalmic Solution |
| VehicleVehicle, one drop in each eye, once daily, for up to 30 days. | Drug | Vehicle |
Primary outcome
Title: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3
Time frame: Baseline (Day 1) to Day 30 (Hour 3)
8 secondary outcomes
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.
Time frame: Through study completion, an average of 60 days
Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)
Time frame: Day 1 and Day 30
Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)
Time frame: Day 1 and Day 30
Maximum plasma concentration(Cmax)
Time frame: Day 1 and Day 30
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 and Day 30
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Day 1 and Day 30
Apparent Terminal Elimination Half-Life (T1/2)
Time frame: Day 1 and Day 30
Apparent total body clearance (CL/F)
Time frame: Day 1 and Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilocarpine HCl Ophthalmic Solution in people with Presbyopia, run by CSPC Ouyi Pharmaceutical Co., Ltd..
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 11 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 (time frame: Baseline (Day 1) to Day 30 (Hour 3)). 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 Jul 2024.