Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-03 @ 5:53 PM
Study NCT ID:
NCT06451666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For arm 1, patients received pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.\n\nFor arm 2, patients received vehicle, one drop in each eye, once daily, for up to 30 days.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Baseline (Day 1) to Day 30 (Hour 3)'}], 'secondaryOutcomes': [{'measure': 'Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc.', 'timeFrame': 'Through study completion, an average of 60 days'}, {'measure': 'Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Maximum plasma concentration(Cmax)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Time to maximum plasma concentration (Tmax)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Apparent Terminal Elimination Half-Life (T1/2)', 'timeFrame': 'Day 1 and Day 30'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'Day 1 and Day 30'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;\n* 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;\n* 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;\n* 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;\n* 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;\n* 6 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;\n* 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;\n* 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;\n* 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;\n* 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;\n* 6 History of cataract surgery, phakic intraocular lens surgery, corneal refractive surgery, radial keratotomy, or any intraocular surgery;\n* 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;\n* 8 Moderate to severe dry eye disease at the screening visit;\n* 9 Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis at the screening visit;\n* 10 Diagnosis of any type of glaucoma or ocular hypertension;\n* 11 Female who have a positive pregnancy test during the screening period, lactating, or planning a pregnancy during the study.'}, 'identificationModule': {'nctId': 'NCT06451666', 'briefTitle': 'Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Ouyi Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia', 'orgStudyIdInfo': {'id': 'SYH9042-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilocarpine HCl Ophthalmic Solution', 'interventionNames': ['Drug: Pilocarpine HCl Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Pilocarpine HCl Ophthalmic Solution', 'type': 'DRUG', 'description': 'Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days', 'armGroupLabels': ['Pilocarpine HCl Ophthalmic Solution']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Vehicle, one drop in each eye, once daily, for up to 30 days.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trials Information Group officer', 'role': 'CONTACT', 'email': 'ctr-contact@cspc.cn', 'phone': '86-0311-69085587'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Ouyi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}