Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Condition: Acanthamoeba Keratitis
MeSH terms: Acanthamoeba Keratitis; Keratitis
Intervention: 0.04% PHMB; 0.06% PHMB; 0.08% PHMB; PHMB Vehicle
Intervention description: 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 eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days; 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 eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Intervention MeSH terms: Biguanides; Polihexanide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

Eligibility 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.