Acanthamoeba Keratitis Clinical Trial
Official title:
Randomized, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% PHMB Ophthalmic Solution in Comparison With 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba Keratitis
Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis. 130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine
This was a randomized, assessor-masked, active-controlled, multiple center, parallel-group phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) ophthalmic solution compared to the conventional 0.02% polihexanide (PHMB) + 0.1% propamidine in patients affected by acanthamoeba keratitis. The study was designed as a superiority study with the possibility to test for non-inferiority if the superiority hypothesis was not met (CPMP/EWP/482/99).The study consisted of an eligibility screening visit, a treatment period including monthly follow-up visits until a clinical resolution was obtained (within a maximum of 1 year), followed by 2 post-treatment off-therapy visits (30 and 90 days after treatment discontinuation). 130 subjects with confirmed diagnosis of acanthamoeba keratitis (clinical signs plus positive confocal microscopy findings) were assigned to one of the following treatment groups in a ratio of 1:1. Group 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02506257 -
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06332703 -
Acanthamoeba and Artificial Intelligence
|
||
| Enrolling by invitation |
NCT03461978 -
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures
|
N/A | |
| Recruiting |
NCT02763605 -
Retrospective Study of Acanthamoebic Keratitis During the Past 10 Years
|
N/A | |
| Active, not recruiting |
NCT03484507 -
Parasitic Ulcer Treatment Trial Pilot
|
Phase 2 | |
| Active, not recruiting |
NCT05110001 -
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
|
Phase 3 | |
| Not yet recruiting |
NCT06213649 -
Parasitic Ulcer Treatment Trial
|
Phase 3 |