The Safety and Efficacy of SYD-101 in Children With Myopia (STAAR)

  • STATUS
    Recruiting
Updated on 16 June 2020
corrected visual acuity
glaucoma
astigmatism
anisometropia
retinal detachment
severe myopia

Summary

Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glaucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Details
Condition Myopia
Clinical Study IdentifierTX246126
Last Modified on16 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 3 yrs and 14 yrs?
Gender: Male or Female
Do you have Myopia?
Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes
Astigmatism ≤1.50 D in both eyes
Anisometropia ≤1.00 D in both eyes
If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria
BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better

Exclusion Criteria

Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly)
Current use of a monoamine oxidase inhibitor
Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis
Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia
History or evidence of ocular surgery or planned future ocular surgery in either eye
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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