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:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06451666
Eligibility Criteria:
Inclusion Criteria:
* 1 Participant must be 40 to 65 years of age inclusive, at the time of the screening visit;
* 2 Emmetropes or non-emmetropes with best distance correction in the range of spherical -4.00 D to +2.00 D inclusively and cylinder ±2.00 D with photopic, high contrast CDVA of 20/25 or better in each eye at the screening and baseline visits;
* 3 Mesopic, high contrast DCNVA of 20/40 to 20/100 in each eye at the screening and baseline visits;
* 4 Photopic, high contrast, near visual acuity correctable to 20/40 or better in each eye at the screening and baseline visits;
* 5 Dark adaptation pupil diameter between 4.0 mm and 8.0 mm in both eyes at the screening visit;
* 6 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
* 1 Clinically significant disease state, in the opinion of the examining investigator or designee, in any body system;
* 2 Known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications;
* 3 Any active ocular inflammation within 30 days prior to the first use of the investigational drug;
* 4 Current enrollment in an study or participation in such a study within 30 days prior to the first use of the investigational drug;
* 5 Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion;
* 6 History of cataract surgery, phakic intraocular lens surgery, corneal refractive surgery, radial keratotomy, or any intraocular surgery;
* 7 Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters;
* 8 Moderate to severe dry eye disease at the screening visit;
* 9 Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis at the screening visit;
* 10 Diagnosis of any type of glaucoma or ocular hypertension;
* 11 Female who have a positive pregnancy test during the screening period, lactating, or planning a pregnancy during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06451666
Study Brief:
Protocol Section:
NCT06451666