CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 90 enrolled
Drug / intervention
0.04% PHMB +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02506257
NCT02506257Phase 1Completed
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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

SIFI SpA·interventional·Posted Jul 23, 2015·Updated Feb 9, 2017

In Brief

A Phase 1 clinical trial evaluating 0.04% PHMB, 0.06% PHMB, and 2 other interventions for Acanthamoeba Keratitis. Completed, enrolled 90 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcanthamoeba Keratitis
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartNov 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.9 years ago

Interventions

0.04% PHMBdrug

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% PHMBdrug

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% PHMBdrug

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 Vehicledrug

PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days