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

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ClinicalTrials.gov Identifier: NCT02506257
Recruitment Status : Completed
First Posted : July 23, 2015
Results First Posted : November 23, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
SIFI SpA

Brief 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

Condition or disease Intervention/treatment Phase
Acanthamoeba Keratitis Drug: 0.04% PHMB Drug: 0.06% PHMB Drug: 0.08% PHMB Drug: PHMB Vehicle Phase 1

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: 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
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
Other Name: Polyhexamethylene Biguanide

Experimental: 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
Drug: 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
Other Name: Polyhexamethylene Biguanide

Experimental: 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
Drug: 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
Other Name: Polyhexamethylene Biguanide

Placebo Comparator: 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
Drug: 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 Outcome Measures :
  1. Number of Subjects With Dose-limiting Adverse Events [ Time Frame: up to 21 days from date of randomization ]

Secondary Outcome Measures :
  1. Plasma Concentration of PHMB [ Time Frame: Day14 ]

Other Outcome Measures:
  1. Systolic Blood Pressure [ Time Frame: Baseline and Day 14 ]
    Change from baseline systolic blood pressure

  2. Visual Acuity [ Time Frame: Baseline and Day 14 ]
    Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.

  3. Ocular Surface Disease Index-OSDI [ Time Frame: Baseline and Day 14 ]
    Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.

  4. Conjunctival Examination [ Time Frame: Baseline and Day 14 ]
    Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506257


Sponsors and Collaborators
SIFI SpA
Investigators
Principal Investigator: I JE van der meulen, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02506257     History of Changes
Other Study ID Numbers: 042SI
First Posted: July 23, 2015    Key Record Dates
Results First Posted: November 23, 2016
Last Update Posted: February 9, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Keratitis
Acanthamoeba Keratitis
Corneal Diseases
Eye Diseases
Eye Infections, Parasitic
Parasitic Diseases
Amebiasis
Protozoan Infections
Eye Infections
Ophthalmic Solutions
Biguanides
Polihexanide
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs
Disinfectants
Anti-Infective Agents