Status:
SUSPENDED
Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS)
Lead Sponsor:
Imperial College London
Conditions:
Glaucoma
Eligibility:
MALE
40-80 years
Phase:
PHASE3
Brief Summary
It is commonly known that high eye pressure is associated with glaucoma. However, there is also a theory that poor circulation to the eye is a contributing factor. Therefore, if we can increase the fl...
Detailed Description
Hypotheses This study is examining the hypothesis that Phosphodiesterase inhibitors increase chorio-retinal blood flow; in other words, we hypothesise that drugs like Viagra that have a known effect ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04052269
Start Date
June 21 2019
End Date
October 30 2022
Last Update
January 25 2021
Active Locations (1)
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1
Western Eye Hospital
London, United Kingdom, NW1 5QH