Health Condition 1: H521- Myopia Health Condition 2: H524- Presbyopia
Conditions
Interventions
None listed
Sponsors
Jagat Pharma Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Equal number of participants will be recruited in the age group of 8 to 16 years and 16 to 30 years 2. Spherical equivalent refraction (SER): -1.00 to -5.00D 3. Parents willing to sign informed consent and allow their children to undergo all the study procedure. Cohort 2: 1. Literate Male or Female between 40 and 55 years of age. 2. Distance-corrected near visual acuity (DCNVA) for each eye, as well as for binocular vision, equivalent to 0.3 logMAR or worse; or 20 by 40 Snellen or worse at 40 cm 3. Subjects willing to sign informed consent and to undergo all the study procedure
Exclusion criteria
Exclusion criteria: Cohort 1: 1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. 2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening. 3. History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.). 4. History of clinically significant systemic disease including hypertension, diabetes, cardiac, endocrine, respiratory, neurologic, down syndrome, etc. that might interfere with the study as deemed by the Investigator 5. History or current history of glaucoma or ocular hypertension. 6. History of any refractive ocular anatomical anomaly (keratoconus, lenticonus, spherophakia, aphakia, etc.). 7. History of ocular diseases, excluding myopia (corneal alterations/opacities, cataract, retinal alterations, inflammatory diseases, etc.). 8. History of any type of ocular surgery. 9. Having participated in clinical research studies 30 days prior to inclusion in the present study. 10. Present active inflammatory or infectious ocular disease at the time of study entry. 11. Having undergone surgical procedures, not ophthalmologic, within the last 3 months. 12. Chronic use of any topical or systemic antimuscarinic/anticholinergic medication (atropine, scopolamine, tropicamide) within 21 days prior to screening, and/or anticipated need for its chronic use during the study period (more than 7 consecutive days in a month or more than 30 days total in a year). 13. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. 14. Known allergy, hypersensitivity, or contraindication to any component of the study medications. 15. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study Cohort 2: 1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. 2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening. 3. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. 4. Recent or current evidence of ocular infection or inflammation in either eye. 5. Any history of herpes simplex or herpes zoster keratitis. 6. History of diabetic retinopathy or diabetic macular edema. 7. Known allergy, hypersensitivity, or contraindication to any component of the study medications. 8. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. 9. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to screening. 10. Any subject with multifocal intraocular lenses will be excluded. 11. History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris. 12. Clinically significant systemic disease including hypertension and diabetes that might interfere with the study as deemed by the Investigator. 13. Participation in any investigational study within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Comparative difference in Autorefraction (Spherical equivalent) Cohort 2: Number of Subjects With greater than or equal to 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm) Timepoint: Baseline visit (Day 0), Every month assessment till 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: 1. Comparative change in clinical symptoms 2. Comparative change in axial length 3. Comparative difference in corneal curvature 4. Comparative difference in visual acuity 5. Comparative assessment of vision targeted health status 6. Global assessment of overall change by investigator and subject 7. Global assessment of tolerability of study products by investigator and subject 8. Assessment of adverse events. Cohort 2: 1). Comparative change in clinical symptoms 2). Quality of Life 3). Comparative assessment of vision targeted health status 4). Global assessment of overall change by investigator and subject 5). Global assessment of tolerability of study products by investigator and subject 6). Assessment of adverse events Timepoint: Baseline visit (Day 0), Every month assessment till 6 months | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed