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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03496467
Eligibility Criteria:
Inclusion Criteria:
1. A male or female subject in good general health, ≥ 22 years of age at the time of the screening visit
2. A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
3. A subject has a lower puncta that can be dilated to 1.0 mm in their scheduled surgical eye
Exclusion Criteria:
1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
2. A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
3. A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye
4. A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
5. A subject with a known sensitivity to nepafenac or any inactive ingredient of the punctum plug, silicone, fluorescein, topical anesthetic, or any other products required for study procedures or cataract surgery
6. A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
99 Years
Study:
NCT03496467
Study Brief:
Protocol Section:
NCT03496467