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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.04% PHMB | Experimental | 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 | Experimental | 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 | Experimental | 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 | Placebo Comparator | PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.04% PHMB | Drug | 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Dose-limiting Adverse Events | up to 21 days from date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of PHMB | Day14 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Change from baseline systolic blood pressure | Baseline and Day 14 |
| Visual Acuity | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I JE van der meulen, MD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33239413 | Derived | Papa V, van der Meulen I, Rottey S, Sallet G, Overweel J, Asero N, Minassian DC, Dart JKG. Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers. Br J Ophthalmol. 2022 Feb;106(2):190-196. doi: 10.1136/bjophthalmol-2020-317848. Epub 2020 Nov 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 0.04% 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 |
| FG001 | 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 0.06% 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 |
| FG002 | 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 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 |
| FG003 | 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 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adult healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 0.04% 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 |
| BG001 | 0.06% PHMB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Dose-limiting Adverse Events | Posted | Number | participants | up to 21 days from date of randomization |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 0.04% 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctival hypermia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. IJE van Der Muelen | AMC Amsterdam | 020 - 566 9111 | TtT@amc.uva.nl |
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| ID | Term |
|---|---|
| D015823 | Acanthamoeba Keratitis |
| ID | Term |
|---|---|
| D015822 | Eye Infections, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000562 | Amebiasis |
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| ID | Term |
|---|---|
| C031233 | polihexanide |
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| 0.06% PHMB | Drug | 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 | Drug | 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 | Drug | PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days |
|
| Baseline and Day 14 |
| Ocular Surface Disease Index-OSDI | Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome. | Baseline and Day 14 |
| Conjunctival Examination | 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 | Baseline and Day 14 |
| Protocol Violation |
|
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days 0.06% 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 |
| BG002 | 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 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 |
| BG003 | 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 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| 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 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 |
| OG003 | 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 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 |
|
|
| Secondary | Plasma Concentration of PHMB | Posted | Mean | Standard Deviation | micrograms/ml | Day14 |
|
|
|
| Other Pre-specified | Systolic Blood Pressure | Change from baseline systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Baseline and Day 14 |
|
|
|
| Other Pre-specified | Visual Acuity | 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. | Posted | Mean | Standard Deviation | decimals | Baseline and Day 14 |
|
|
|
| Other Pre-specified | Ocular Surface Disease Index-OSDI | Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Day 14 |
|
|
|
| Other Pre-specified | Conjunctival Examination | 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 | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Day 14 |
|
|
|
| 0 |
| 26 |
| 11 |
| 26 |
| EG001 | 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 0.06% 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 | 28 | 23 | 28 |
| EG002 | 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 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 | 0 | 27 | 16 | 27 |
| EG003 | 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 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 | 0 | 9 | 5 | 9 |
| Instillation site pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| conjunctival staining | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| corneal staining | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| eyelid edema | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Instillation site pain erythema | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Instillation site pruritus | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Instillation site foreign body sensation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| eye pain | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
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| D011528 |
| Protozoan Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |