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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02506257
Other study ID # 042SI
Secondary ID
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


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
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