Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06071260
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with myopia
* Able to read and comprehend Chinese and willing to give informed consent as demonstrated by signing a record of informed consent.
* Be between 18 and 60 years old, male or female.
* Willing to apply eye drops once nightly at bedtime for one time and follow the clinical trial visit schedule as directed by the Investigator.
* Willing to answer the questionnaire about subjective measurements.
* Have ocular findings deemed to be myopic.
* No history of wearing contact lens.
* Vision correctable to at least 20/25 or better in each eye with spectacles.
Exclusion Criteria:
* Any pre-existing ocular irritation, injury or condition, including infection or disease.
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. - - Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent ocular medication at enrolment and/or during the clinical trial.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
* History of eye surgery
* History of use of any myopia control interventions such as Orthokeratology, Rigid Permeable Contact Lenses Eye surgery within 12 weeks immediately prior to enrolment for this trial.
* Currently treated with other interventions for myopia control
* Contraindications to atropine such as pulmonary disease, heart conditions and ADHD
* Known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents.
* Currently enrolled in another clinical trial.
NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06071260
Study Brief:
Protocol Section:
NCT06071260