Presbyopia patients/near vision blur
Conditions
Interventions
Test group:Pilocarpine hydrochloride Ophthalmic Solution
placebo group:simulated eye drops of pilocarpine hydrochloride
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: Both male and female; 2. Age: 40 years old and above (including 40 years old); 3. The subject complained of poor vision affecting normal life, and at least one of the main questions 5-7 and optional additional questions A3-A5 in the National Eye Institute Visual Function Questionnaire (NEI VFQ, see Appendix 2) had a score of >= 3 (moderate impact) during screening; 4. Obviously, the optometry results are -4.00 D to+2.00 D for spherical lenses (including -4.00 D and+2.00 D), and = 20/25 under bright light; 5. Mesopic, high contrast DCNVA of 20/40 (J3) to 20/100 (J10) in each eye at the screening and baseline visits; 6. Photopic, high contrast, near visual acuity correctable to 20/40 (J3+) or better in each eye at the screening and baseline visits; 7. Under bright light, the pupil diameter of both eyes is less than 8mm; 8. The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as subjects, and sign an informed consent form before any research procedure begins;
Exclusion criteria
Exclusion criteria: 1.Individuals with uncontrollable systemic diseases, or those with existing serious disease states such as liver, kidney, digestive tract, endocrine system, cardiovascular and cerebrovascular system, nervous system, metabolic system, hematological system, respiratory system, and autoimmune system, who are deemed unsuitable for inclusion by the researcher; 2.Screening for subjects who have undergone ophthalmic surgery within the previous 3 months, or plan to undergo ophthalmic surgery during the study period, or have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion, such as cataract surgery history, corneal transplantation surgery history, radial keratotomy history, or any history of intraocular lens surgery; 3.Allergy: Individuals who have previously been allergic to any component of pilocarpine hydrochloride and excipients, or allergic to other cholinergic drugs; 4.Current history of using temporary or permanent lacrimal punctum plugs or lacrimal punctum burns in one or both eyes; 5.There are eye diseases that researchers believe affect the safety or efficacy evaluation of subjects, such as uveitis and retinal detachment; 6.Previously diagnosed with severe dry eye or diagnosed as severe dry eye disease during screening (defined as corneal injury range of 2 quadrants or more and/or corneal fluorescence staining points = 30 on slit lamp biomicroscopy, tear film rupture time (BUT)21mmHg, is deemed unsuitable for participants based on comprehensive evaluation by the researchers; 11.Screening for individuals who have used drugs that may have a significant impact on visual function or optical properties in the previous 2 weeks, such as systemic drugs with potential eye side effects, including topiramate, hydroxychloroquine, ethambutol, phosphodiesterase 5 inhibitors (sildenafil, vardenafil, tadalafil), or tamoxifen; Eye, systemic, or intranasal anticholinergic drugs and alpha adrenergic receptor agonists with potential pupil regulating effects, including hydroxymetazoline, pilocarpine, tetrahydrozoline, phenylephrine, naphthozoline, cyclopentenyl ester (except for mydriatic refraction), topiramine (except for mydriatic refraction), atropine, beta blockers, or antihistamines; Whole body use of maprotiline, tricyclic antidepressants such as amitriptyline, antipsychotic drugs such as sulfamethoxazole, and anti Parkinson's drugs such as pheniramine; 12.Individuals who have taken any clinical trial drugs or used any clinical trial devices within the past 3 months prior to screening; 13.Pregnant, lactating women or women of childbearing age who plan to conceive (defined as premenopausal or postmenopausal women who have not undergone surgical sterilization for less than 1 year); 14.Researchers believe that due to other reasons, participants are not suitable to participate in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCNVA and binocular BCDVA at best distance corrected visual acuity with intermediate vision and high contrast in both eyes; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCNVA at best distance corrected visual acuity with intermediate vision and high contrast in both eyes;DCNVA at best distance corrected visual acuity with bright light and high contrast in both eyes;DCIVA at best distance corrected visual acuity with bright light and high contrast in both eyes; | — |
Countries
China
Contacts
Public ContactJia Qu
Eye Hospital, Wenzhou Medical University
Outcome results
None listed