Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Atropine Sulfate 0.05% w/v ophthalmic solution: One drop to be instilled once a day preferably at night in each eye for 12 months
Control Intervention1: Atropine Sulfate 0.01% w/v ophth
Sponsors
Entod Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female child subjects of age between 6 to 12 years (at the time of consenting). 2. Subjects with normal ocular health other than myopia. 3. Refractive error of spherical equivalent (SE) range of –0.50 D to -6.00 D in both eyes. 4. Best-corrected distance visual acuity (BCDVA) 0.20 logMAR or better in both eyes. 5. The Investigator believes that the subject and subject’s parent(s) or Legally Acceptable Representative(s) (LAR(s)) will comply with the requirements of the protocol. 6. Written informed consent /assent obtained from the subject and parent(s)/LAR(s) of the subject for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent. 2.Astigmatism of more than -1.5 D in either eye measured by cycloplegic autorefraction. 3.Allergy or hypersensitivity to atropine sulfate or excipients. 4.Abnormality of the cornea, lens, central retina, iris or ciliary body. 5.Current or prior history of ocular diseases (e.g., cataract, congenital retinal diseases, amblyopia, and strabismus. 6.Medical conditions predisposing patient to degenerative myopia, abnormal ocular refractive anatomy, and/or history of any other ocular diseases or ocular surgery. 7.History of any systemic diseases (e.g. cardiac, respiratory, endocrine, neurological, kidney or urinary disease or dysfunction). 8.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. 9.Participation in any study of an investigational, interventional product within 30 days prior to Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in spherical equivalent refractive error from baseline to 12 months, measured by cycloplegic autorefractionTimepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The proportion of subjects showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction. 2.Mean change in ocular axial length from baseline to 12 months. 3.Mean change in pupil size from baseline to 12 months. 4.Mean change in accommodation amplitude (D) from baseline to 12 months 5.Mean change in visual acuity from baseline to 12 months.Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed