Trial Outcomes & Findings for Smart Touch Non-dispensing Handling Studies (NCT NCT03253393)

NCT ID: NCT03253393

Last Updated: 2021-12-03

Results Overview

Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

After 45 minutes of lens wear

Results posted on

2021-12-03

Participant Flow

25 subjects were required to complete each of the three study interventions

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.

Participant milestones

Participant milestones
Measure	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)	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.	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.
First Intervention STARTED	12	13	0
First Intervention COMPLETED	12	13	0
First Intervention NOT COMPLETED	0	0	0
Washout (Minimum 48 Hours) STARTED	12	13	0
Washout (Minimum 48 Hours) COMPLETED	6	6	0
Washout (Minimum 48 Hours) NOT COMPLETED	6	7	0
Second Intervention STARTED	12	13	0
Second Intervention COMPLETED	12	13	0
Second Intervention NOT COMPLETED	0	0	0
Third Intervention STARTED	6	6	13
Third Intervention COMPLETED	6	6	13
Third Intervention NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	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.	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.
Washout (Minimum 48 Hours) 13 participants exited study after first two visits/interventions	6	7	0

Baseline Characteristics

Smart Touch Non-dispensing Handling Studies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SiH (With EDTA) , Then H (no EDTA), Then SiH (Without EDTA) and H (With EDTA) in Smart Touch n=12 Participants 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.	H (no EDTA), Then SiH (With EDTA), Then SiH (Without EDTA) vs H (With EDTA) in Smart Touch n=13 Participants 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.	SiH (Without EDTA) in Smart Touch vs H (With EDTA) in Smart Touch n=13 Participants 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.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	29.8 years STANDARD_DEVIATION 8.8 • n=5 Participants	29.8 years STANDARD_DEVIATION 8.8 • n=7 Participants	30.1 years STANDARD_DEVIATION 14.2 • n=5 Participants	29.9 years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Non-Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Australia	12 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	38 participants n=4 Participants

PRIMARY outcome

Timeframe: After 45 minutes of lens wear

Number of Participants Without Contamination of Contact Lenses after 45 minutes of wear

Outcome measures

Outcome measures
Measure	Silicone Hydrogel (With EDTA) in Smart Touch n=25 Participants Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (with EDTA).	Silicone Hydrogel (With EDTA) in Conventional Packaging n=25 Participants Lens Contamination for Silicone hydrogel (with EDTA) in conventional packaging	Silicone Hydrogel (no EDTA) in Smart Touch n=25 Participants Lens Contamination for Silicone Hydrogel lenses in Smart Touch™ (no EDTA).	Hydrogel (no EDTA) in Smart Touch n=25 Participants Lens Contamination for Hydrogel lenses in Smart Touch™ (no EDTA).	Hydrogel (no EDTA) in Conventional Packaging n=25 Participants Lens Contamination for Hydrogel in Conventional packaging (no EDTA).	Hydrogel (With EDTA) in Smart Touch n=25 Participants Lens Contamination for Hydrogel lenses in Smart Touch™ (with EDTA).
Number of Participants Without Contamination of Contact Lenses	16 Participants	9 Participants	4 Participants	14 Participants	7 Participants	16 Participants

SECONDARY outcome

Timeframe: After 45 minutes of lens wear

Bacterial counts of contact lenses after 45 minutes of wear (CFU count /lens)