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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT04052269
Eligibility Criteria:
Inclusion Criteria:
* Able to give informed consent to participate in the study
* Aged between 40 and 80 years of age
* Clear optical media
* Spherical equivalent +-10D
* IOP 21mmHg
Exclusion Criteria:
* have used sildenafil for 48 hours (4 hour half-life) and tadalafil for 5 days (48 hour half-life).
* have a known adverse reaction to any phosphodiesterase inhibitors
* have an inherited photoreceptor disease (manufacturer contra-indication)
* have any other known ocular disease (except glaucoma in this cohort)
* have had non-arteritic anterior ischaemic optic neuropathy (manufacturer precaution due to lack of long term visualfield studies)
* are on current ritonavir, erythromycin, cimetidine treatment (Manufacturer advises if concurrent use of ritonavir is unavoidable, the max. dose should not exceed 25 mg within 48 hours)
* have serious cardiac or liver disease (manufacturer contra-indication)
* have had a stroke or myocardial infarction (manufacturer contra-indication) within 6 months
* have anatomical deformation of the penis or conditions predisposing to priapism (sickle cell anaemia, leukaemia, multiple myeloma)
* have hypotension (manufacturer contra-indication) BP\<100/60
* have secondary or narrow/closed angle glaucoma
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04052269
Study Brief:
Protocol Section:
NCT04052269