Health Condition 1: H524- Presbyopia
Conditions
Interventions
Intervention1: Pilocarpine Hydrochloride Ophthalmic solution USP 1.25 % w/v: One drop of Pilocarpine Hydrochloride Ophthalmic solution USP 1.25 % w/v once daily in each eye (preferably in morning) for
Sponsors
Entod Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female participants, 45 to 55 years of age (both inclusive). 2. Participants with subjective complaints of poor near vision that impacts the activity of daily living. 3. Participants with photopic, high-contrast Corrected Distance Visual Acuity (CDVA) of 20/25 or better bilaterally; mesopic, high-contrast Distance-Corrected Near Visual Acuity (DCNVA, measured at 40cm) of 20/40 to 20/100; photopic, near visual acuity correctable to 20/40 or better bilaterally. 4. Participants with willingness to wear monofocal correction to achieve photopic, binocular CDVA of 20/32 or better during the study. 5. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation or cholinergic agonist medications. 2. Participants with history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any other intraocular surgery. 3. Participants with concurrent use of any topical ophthalmic medications including artificial tears, other than the study intervention during the course of the study. 4. Participants with concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes. 5. Participants with severe dry eye disease. 6. Participants with pathological myopia. 7. Participants with corneal abnormalities (including Keratoconus,corneal scar, Fuchs endothelial dystrophy, guttata or edema) in either eye that are likely to interfere the visual acuity. 8. Participants with history of iris trauma, Adies tonic pupil, abnormal pupil shape in either eye, or anisocoria greater than 1mm between pupils under mesopic conditions at the screening visit. 9. Participants with all grades of cataract. 10. Participants with diagnosis of Glaucoma or ocular Hypertension. 11. Narrow iridocorneal angles (Shaffer grade less than or equal to 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy. 12. Participants with Bifocal or multifocal spectacles or contact lenses for habitual correction. 13. Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy. 14. Participants with history of chronic, recurrent, or current severe inflammatory eye disease (i.e.scleritis, uveitis, herpes keratitis) in either eye. 15. Participants with documented history of ocular trauma 6 months before the study. 16. Participants with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, retinal hole or tear, diabetic retinopathy, retinal detachment, peripheral retina is showing lattice degeneration) in either eye. 17. Participants with use of topical ophthalmic corticosteroid within two weeks prior to baseline visit. 18. Participants with use of intraocular corticosteroid implant at any time prior to baseline visit. 19. Presence of a severe or serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow up. 20. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic and renal diseases. 21. Participants currently participating in any other clinical trial or has participated in any other clinical trial 30 days prior to screening. 22. Suspected inability or unwillingness to comply with the protocol or other study procedures. 23. Female participants who are pregnant or lactating or planning to become pregnant during the study period. Females or males who are not ready to use acceptable contraceptive methods during the course of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The assessment of the safety of participants [Based on the incidence of treatment emergent adverse event(TEAE)]. 2.The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.Timepoint: 150 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants Gaining 3 Lines or More in Mesopic (10-11 lux at the target), High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) on Day 120, hours 3, 6 and 9 [Time Frame: Baseline Day 1 to Day 120 (Hours 3, 6 and 9)].Timepoint: 120 Days;2. Proportion of participants Achieving 20/40 or Better in Photopic (Greater than 251 lux at the target), High-contrast, Binocular, DCNVA on Day 120, hour3[ Time Frame: Day 120 (Hour 3)].Timepoint: 120 Days;3. Mean change from baseline in photopic, high-contrast, binocular Distance-Corrected Intermediate Visual Acuity (DCIVA; measured at 66 cm) letters on Day 120, hour 3 [Time Frame: Day 1 to Day 120 (Hour 3)].Timepoint: 120 Days;4. Mean Change from Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score on Day 120, Hour 3.Timepoint: 120 Days;5. Mean Change from Baseline in Pelli-Robson contrast measurement score on Day 120.Timepoint: 120 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed