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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03274895
Other study ID # 043/SI
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 13, 2017
Est. completion date March 30, 2022

Study information

Verified date August 2023
Source SIFI SpA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PHMB 0.08%
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Propamidine 0.1%
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
placebo
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
PHMB 0.02%
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution

Locations

Country Name City State
Italy San Raffaele Hospital Milano
Italy San Giovanni and Paolo Hospital Venice
Poland University Clinical Center Medical University of Silesia Katowice
United Kingdom Moorfields Hospital London
United Kingdom Manchester Royal Eye Hospital Manchester
United Kingdom University Hospital Southampton Southampton

Sponsors (1)

Lead Sponsor Collaborator
SIFI SpA

Countries where clinical trial is conducted

Italy,  Poland,  United Kingdom, 

References & Publications (2)

Papa V, Rama P, Radford C, Minassian DC, Dart JKG. Acanthamoeba keratitis therapy: time to cure and visual outcome analysis for different antiamoebic therapies in 227 cases. Br J Ophthalmol. 2020 Apr;104(4):575-581. doi: 10.1136/bjophthalmol-2019-314485. Epub 2019 Aug 10. — View Citation

Papa V, van der Meulen I, Rottey S, Sallet G, Overweel J, Asero N, Minassian DC, Dart JKG. Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers. Br J Ophthalmol. 2022 Feb;106(2):190-196. doi: 10.1136/bjophthalmol-2020-317848. Epub 2020 Nov 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Resolution Rate Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization 12 months
Secondary Time to Cure Time needed to reach a clinical resolution maximum 12 months
Secondary Visual Acuity Final visual acuity (best corrected) maximum 12 months
See also
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