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:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
NCT ID:
NCT05315206
Eligibility Criteria:
Inclusion Criteria:
* Age between 20 and 70 years old
* Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey 24-2 standard SITA with mean deviation between -6 and -25 dB) and glaucomatous appearance of the optic nerve
* Visual acuity not less than 5/10
* Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase inhibitors. Such drugs can be used both alone and in combination with each other.
* Documented post-retinal nerve conduction delay through simultaneous recording of VEP and PERG showing an increase in RCT
Exclusion Criteria:
* Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
* Cataract or maculopathy
* Argon laser trabeculoplasty (ALT) within the previous 6 months
* Known hypersensitivity to the study product
* Secondary causes of ocular hypertension, including systemic or topical use of steroids
* Positive history of ocular or systemic diseases that could preclude enrollment in the study in the opinion of the investigators
* Changes in systemic therapies that could compromise intraocular pressure values (beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the 30 days prior to enrollment
* Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin, retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and / or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine, Citicoline and / or its derivatives must have been suspended at least 6 months prior to inclusion in the study)
* Pregnancy, breastfeeding
* Diabetes
* Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
* Concomitant use of anticoagulants and lithium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT05315206
Study Brief:
Protocol Section:
NCT05315206