Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
This trial is active, not recruiting.
|Treatments||0.04% phmb, 0.06% phmb, 0.08% phmb, phmb vehicle|
|Start date||November 2015|
|End date||March 2016|
|Trial size||90 participants|
|Trial identifier||NCT02506257, 042SI|
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
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Number of subjects with adverse events
time frame: up to 21 days from date of randomization
Plasma concentration of PHMB
time frame: Day7 and Day14
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.
|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|
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