Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v: One drop of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v to be administered once a day preferably at night
Sponsors
Entod Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female child participants of age between Six to Fifteen years (both inclusive). 2. Participants with normal ocular health other than myopia. 3. Participants with refractive error of spherical equivalent (SE) range of minus 0.50 D to minus 6.00 D in both eyes. 4. Participants with Best-corrected distance visual acuity BCDVA 0.20 log MAR or better in both eyes. 5. The Investigator believes that the participant and participant s parent or Legally Acceptable Representative LAR will comply with the requirements of the protocol. 6. Written assent informed parental consent obtained from the participant and parent/LAR of the participant for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medications or any of the ingredients of the formulation. 2. Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agents. 3. Participants with astigmatism of more than minus 1.5 D in either eye measured by cycloplegic autorefraction. 4. Participants with abnormality of the cornea, lens, central retina, iris or ciliary body. 5. Participants with current or prior history of ocular diseases (e.g., cataract, congenital retinal diseases, amblyopia, and strabismus). 6. Medical conditions predisposing participant to degenerative myopia, abnormal ocular refractive anatomy, and/or history of any other ocular diseases or ocular surgery. 7. Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow-up. 8. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal and neurological diseases or any congenital conditions. 9. Suspected inability or unwillingness to comply with the protocol or other study procedures. 10. Participants currently participating in any other clinical trial or has participated in any other clinical trial thirty days prior to screening.
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: 52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in spherical equivalent refractive error from baseline to week 52, measured by cycloplegic autorefraction.Timepoint: 52 Weeks;The proportion of participants showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.Timepoint: 52 Weeks;Mean change in ocular axial length from baseline to week 52.Timepoint: 52 Weeks;Mean change in pupil size from baseline to week 52.Timepoint: 52 Weeks;Mean change in accommodation amplitude (D) from baseline to week 52.Timepoint: 52 Weeks;Mean change in visual acuity from baseline to week 52. Timepoint: 52 Weeks | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed