Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Menicon Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
This study is a randomized, contralateral, investigator-masked non-dispensing study, to investigate the microbial contamination rates on the back surface of two types of soft contact lenses (hydrogel and silicone hydrogel) extracted from Smart Touch Technology blister packs versus conventional lens packaging after short-term placement on the eye, and to compare the microbial contamination rates of the worn contact lenses to those on the participants' hands/fingers used to conduct lens insertion.
This will be a prospective, single centre, randomized, contralateral, investigator-masked non-dispensing study. This study requires three visits of approx. 1 hour duration each.
At the first visit, the order in which the hydrogel (no EDTA) and silicone hydrogel (with EDTA) contact lenses are allocated to the study participants will be randomized. At the second visit, participants will be crossed over to the alternate lens type (hydrogel no EDTA or silicone hydrogel with EDTA).
At the third visit, participants will be randomly allocated to wear the hydrogel lens (with EDTA) in one eye and the silicone hydrogel lens (no EDTA) in the other eye, both removed from Smart Touch Technology packaging.
At each visit, participants will be instructed to:
Lenses and finger swabs will be analysed for microbial contamination using established routine microbiology protocols. The number and species of organisms will be determined.
A minimum washout period of 48 hours will occur between the study visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging | Experimental | Silicone hydrogel (with EDTA) in Smart Touch vs. in conventional packaging |
|
| Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging | Experimental | Hydrogel (no EDTA) in Smart Touch vs. in conventional packaging |
|
| Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch | Experimental | Silicone hydrogel (no EDTA) vs. hydrogel (with EDTA) in Smart Touch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Touch Technology packaging | Device | hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Without Contamination of Contact Lenses | Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear | After 45 minutes of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Counts of Worn Contact Lenses | Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens) | After 45 minutes of lens wear |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry and Vision Science | Sydney | New South Wales | 2052 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33973914 | Derived | Tan J, Siddireddy JS, Wong K, Shen Q, Vijay AK, Stapleton F. Factors Affecting Microbial Contamination on the Back Surface of Worn Soft Contact Lenses. Optom Vis Sci. 2021 May 1;98(5):512-517. doi: 10.1097/OPX.0000000000001693. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
25 subjects were enrolled and randomised. Of those randomised, 13 did not complete the third visit/intervention. Therefore an additional 13 subjects were recruited to complete the third intervention only.
25 subjects were required to complete each of the three study interventions
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch | Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye. Smart Touch Technology packaging: midafilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel, with EDTA) Conventional lens packaging: hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA) |
| FG001 | H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch | Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye. |
| FG002 | SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch | Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (Minimum 48 Hours) |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Washout (Minimum 48 Hours) |
| |||||||||||||
| Third Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch | Participants first received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participants Without Contamination of Contact Lenses | Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear | Posted | Count of Participants | Participants | After 45 minutes of lens wear |
|
Participants were monitored for adverse events occurring during lens wear i.e. 45 minutes for each visit, up to 3 visits.
Participants were monitored for adverse events at each visit
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silicone Hydrogel (With EDTA) in Smart Touch | Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacqueline Tan | University of New South Wales | +612 9385 6551 | jacqueline.tan@unsw.edu.au |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | May 24, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Contralateral study
Not provided
Not provided
Not provided
| Conventional lens packaging | Device | hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA) |
|
| EDTA | Device | hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA) |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG001 | H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch | Participants first received a Hydrogel lens (no EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours, they then received a Silicone Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in one eye and a Silicone Hydrogel lens (with EDTA) in a conventional blister which was inserted in the other eye. After a minimum washout period of 48 hours they then received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging in the other eye. |
| BG002 | SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch | Participants received a Silicone Hydrogel lens (without EDTA) in Smart Touch packaging which was inserted in one eye and a Hydrogel lens (with EDTA) in Smart Touch packaging which was inserted in the other eye. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA). |
| OG003 | Hydrogel (no EDTA) in Smart Touch | Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA). |
| OG004 | Hydrogel (no EDTA) in Conventional Packaging | Lens Contamination for Hydrogel in Conventional packaging (no EDTA). |
| OG005 | Hydrogel (With EDTA) in Smart Touch | Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA). |
|
|
| Secondary | Bacterial Counts of Worn Contact Lenses | Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens) | Posted | Median | Inter-Quartile Range | CFU count per lens | After 45 minutes of lens wear | Lens | Lens |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Silicone Hydrogel (With EDTA) in Conventional Packaging | Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Silicone Hydrogel (no EDTA) in Smart Touch | Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA). | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Hydrogel (no EDTA) in Smart Touch | Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA). | 0 | 25 | 0 | 25 | 0 | 25 |
| EG004 | Hydrogel (no EDTA) in Conventional Packaging | Lens Contamination for Hydrogel in Conventional packaging (no EDTA). | 0 | 25 | 0 | 25 | 0 | 25 |
| EG005 | Hydrogel (With EDTA) in Smart Touch | Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA). | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| Lens |
|