Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects

Acanthamoeba Keratitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02506257
• Other study ID #: 042SI
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 20, 2015
• Last updated: February 26, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acanthamoeba Keratitis

Intervention

Drug:
• 0.04% PHMB
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
• 0.06% PHMB
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
• 0.08% PHMB
0.08% PHMB 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SIFI SpA

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic blood pressure	Change from baseline systolic blood pressure	Day7	Yes
Other	Visual acuity	Change from baseline Visual acuity	Day7	Yes
Other	Ocular surface disease index (OSDI)	Change from baseline OSDI at D7	Day7	Yes
Other	Conjunctival examination	Change from baseline conjunctival characteristics at D7	Day7	Yes
Primary	Number of subjects with adverse events		up to 21 days from date of randomization	Yes
Secondary	Plasma concentration of PHMB	Presence of PHMB in plasma	Day7 and Day14	Yes