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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06128369
Eligibility Criteria:
Inclusion Criteria (Selection):
* Provide written informed consent, approved by the appropriate ethics committee;
* Able to comply with the study requirements and visit schedule;
* At least 18 years of age of either sex or any race;
* Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
* Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]);
Exclusion Criteria:
* Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
* Have only one functional eye (monocular);
* Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit-lamp examination;
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye \*Additional inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06128369
Study Brief:
Protocol Section:
NCT06128369