Overview

This trial is active, not recruiting.

Condition acanthamoeba keratitis
Treatments 0.04% phmb, 0.06% phmb, 0.08% phmb, phmb vehicle
Phase phase 1
Sponsor SIFI SpA
Start date November 2015
End date March 2016
Trial size 90 participants
Trial identifier NCT02506257, 042SI

Summary

Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% phmb Polyhexamethylene Biguanide
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
(Experimental)
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% phmb Polyhexamethylene Biguanide
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
(Experimental)
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% phmb Polyhexamethylene Biguanide
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
(Placebo Comparator)
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
phmb vehicle
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

Primary Outcomes

Measure
Number of subjects with adverse events
time frame: up to 21 days from date of randomization

Secondary Outcomes

Measure
Plasma concentration of PHMB
time frame: Day7 and Day14

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - able and willing to give informed consent. - man or woman of any race and 18 to 55 years of age, inclusive. - Body Mass Index of 20-30 kg/m2 - willing and able to attend required study visits. - bilateral visual acuity >6/10. - intraocular pressure (IOP) of 14-21 mmHg. - ophthalmologic examination without abnormalities. - medical history without major pathology. - laboratory test results without deviations from the normal range. - female subjects of childbearing potential with negative urine pregnancy test and using effective contraception during the study. Exclusion Criteria: - presence of bacterial ocular infections. - presence of any concomitant ocular pathology. - performing activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking). - contact lenses wearing . - ocular surface fluorescein staining score >3. - use of topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening. - known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments. - ocular surgery performed within 12 months before screening. - participation in another clinical study in the preceding 30 days. - one functional eye. - pregnancy or breastfeeding. - use of recreational drugs.

Additional Information

Official title Randomized, Double-Masked, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety and Tolerability of Different Doses of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Principal investigator I JE van der meulen, MD
Description The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by SIFI SpA.