Optometry
Conditions
Brief summary
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.
Detailed description
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: * Wash their hands prior to handling the contact lenses; * Swab their thumb and two index fingers of the hand routinely used to conduct contact lens insertion using a sterile cotton swab moistened with sterile preservative free saline for the evaluation of skin microbiota; * Follow the manufacturer's guidelines for lens insertion; * Open the blister pack and insert the contact lens randomly assigned for the right eye; * Open the blister pack and insert the contact lens assigned for the left eye; * Contact lenses will be removed aseptically by a masked investigator after 45 minutes of lens wear. 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.
Interventions
DEVICESmart Touch Technology packaging
hioxifilcon A contact lens in Smart Touch Technology (hydrogel, no EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, with EDTA)
DEVICEConventional lens packaging
hioxifilcon A contact lens in conventional lens packaging (hydrogel, no EDTA) midafilcon A contact lens in conventional lens packaging (silicone hydrogel, with EDTA)
DEVICEEDTA
hioxifilcon A contact lens in Smart Touch Technology (hydrogel, with EDTA) midafilcon A contact lens in Smart Touch Technology (silicone hydrogel, no EDTA)
Sponsors
Menicon Co., Ltd.
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Intervention model description
Contralateral study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to read and comprehend English and give informed consent as demonstrated by signing a Participant Information Statement and Consent Form; * Be at least 18 years old; * Experienced soft contact lens wearer; * Willing to refrain from wearing contact lenses for 24 hours prior to the scheduled study visit
Exclusion criteria
* Under 18 years old; * Have any active corneal infection, ocular disease or systemic disease that would affect wearing of contact lenses; * Use or have a need for any systemic or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology either in an adverse manner or risk providing a false positive; * Have had eye surgery within 12 weeks immediately prior to enrolment for this trial; * Have contraindications to contact lens wear; * Have a greater than 2 line reduction in habitual visual acuity while wearing the study contact lenses; * Be currently enrolled in another clinical trial; * Be pregnant (verbal self-report)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without Contamination of Contact Lenses | After 45 minutes of lens wear | Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Counts of Worn Contact Lenses | After 45 minutes of lens wear | Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens) |
Countries
Australia
Participant flow
Recruitment details
25 subjects were required to complete each of the three study interventions
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 13 |
| 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. | 13 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Washout (Minimum 48 Hours) | 13 participants exited study after first two visits/interventions | 6 | 7 | 0 |
Baseline characteristics
| Characteristic | SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch | H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch | SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 10 Participants | 35 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 8.8 | 29.8 years STANDARD_DEVIATION 8.8 | 30.1 years STANDARD_DEVIATION 14.2 | 29.9 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized Asian | 8 Participants | 10 Participants | 8 Participants | 26 Participants |
| Race/Ethnicity, Customized Non-Asian | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Region of Enrollment Australia | 12 participants | 13 participants | 13 participants | 38 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants Without Contamination of Contact Lenses
Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear
Time frame: After 45 minutes of lens wear
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silicone Hydrogel (With EDTA) in Smart Touch | Number of Participants Without Contamination of Contact Lenses | 16 Participants |
| Silicone Hydrogel (With EDTA) in Conventional Packaging | Number of Participants Without Contamination of Contact Lenses | 9 Participants |
| Silicone Hydrogel (no EDTA) in Smart Touch | Number of Participants Without Contamination of Contact Lenses | 4 Participants |
| Hydrogel (no EDTA) in Smart Touch | Number of Participants Without Contamination of Contact Lenses | 14 Participants |
| Hydrogel (no EDTA) in Conventional Packaging | Number of Participants Without Contamination of Contact Lenses | 7 Participants |
| Hydrogel (With EDTA) in Smart Touch | Number of Participants Without Contamination of Contact Lenses | 16 Participants |
Secondary
Bacterial Counts of Worn Contact Lenses
Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)
Time frame: After 45 minutes of lens wear
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Silicone Hydrogel (With EDTA) in Smart Touch | Bacterial Counts of Worn Contact Lenses | 0 CFU count per lens |
| Silicone Hydrogel (With EDTA) in Conventional Packaging | Bacterial Counts of Worn Contact Lenses | 1 CFU count per lens |
| Silicone Hydrogel (no EDTA) in Smart Touch | Bacterial Counts of Worn Contact Lenses | 4 CFU count per lens |
| Hydrogel (no EDTA) in Smart Touch | Bacterial Counts of Worn Contact Lenses | 0 CFU count per lens |
| Hydrogel (no EDTA) in Conventional Packaging | Bacterial Counts of Worn Contact Lenses | 1 CFU count per lens |
| Hydrogel (With EDTA) in Smart Touch | Bacterial Counts of Worn Contact Lenses | 0 CFU count per lens |