Trial Outcomes & Findings for Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis (NCT NCT02939950)

Last Updated: 2019-12-23

Results Overview

For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).

Recruitment status

COMPLETED

Study phase

Target enrollment

816 participants

Primary outcome timeframe

Month 12

Results posted on

2019-12-23

Participant Flow

A total of 1632 eyes from 816 study participants were enrolled, of which 1612 eyes from 806 study participants were randomized into 1:1 to wear either the Bausch + Lomb samfilcon A soft contact lens or Bausch + Lomb pure vision soft contact lens.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
Overall Study STARTED	406 812	410 820
Overall Study Dispensed the Assigned Lenses	405 810	410 820
Overall Study Eligible at Baseline	403 806	402 804
Overall Study COMPLETED	340 680	329 658
Overall Study NOT COMPLETED	66 132	81 162

Reasons for withdrawal

Reasons for withdrawal
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
Overall Study Lost to Follow-up	13	16
Overall Study Positive slit lamp findings	0	1
Overall Study Chalazion upper lid	0	1
Overall Study Lack of motivation	0	2
Overall Study Unacceptable distance lens visual acuity	1	1
Overall Study Military orders	1	0
Overall Study Participant Relocated	5	3
Overall Study Study related symptoms	8	8
Overall Study Unacceptable lens movement	2	0
Overall Study Protocol Violation	6	3
Overall Study Physician Decision	2	0
Overall Study Pregnancy	6	7
Overall Study Withdrawal by Subject	12	28
Overall Study Adverse Event	7	3
Overall Study Randomized, not dispensed	1	0
Overall Study Ineligible at Baseline	2	8

Baseline Characteristics

Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens n=806 Eyes Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens n=804 Eyes Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Total n=1610 Eyes Total of all reporting groups
Age, Continuous	29.8 years STANDARD_DEVIATION 6.2 • n=5 Participants	29.2 years STANDARD_DEVIATION 6.1 • n=7 Participants	29.5 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	263 Participants n=5 Participants	265 Participants n=7 Participants	528 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	137 Participants n=7 Participants	277 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Analysis set included all eligible dispensed participants under the treatment they actually received. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens n=669 eyes Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens n=652 eyes Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
High Contrast Visual Acuity	-0.065 logMAR Standard Deviation 0.067	-0.047 logMAR Standard Deviation 0.071

PRIMARY outcome

Timeframe: Baseline up to Month 12

Population: Safety analysis set included all dispensed participants.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.

Outcome measures

Outcome measures
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens n=405 Participants Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens n=410 Participants Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
Number of Participants With Adverse Events	22 Participants	14 Participants

Adverse Events

Bausch + Lomb Samfilcon A Soft Contact Lens

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Bausch + Lomb Pure Vision Soft Contact Lens

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bausch + Lomb Samfilcon A Soft Contact Lens n=405 participants at risk Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.	Bausch + Lomb Pure Vision Soft Contact Lens n=410 participants at risk Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month.
Eye disorders Peripheral Non-Progressive Non-Infectious Corneal Ulcer	0.74% 3/405 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.	0.73% 3/410 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.
Eye disorders Symptomatic Corneal Infiltrative Event	3.7% 15/405 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.	0.98% 4/410 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.
Eye disorders Corneal Staining greater than or equal to Grade 3	0.99% 4/405 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.	0.73% 3/410 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.
Eye disorders Ocular Event that necessitates temporary lens discontinuation for atleast two weeks	0.00% 0/405 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.	0.98% 4/410 • Baseline up to Month 12 Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.

Additional Information

Director of Clinical Operations

Bausch Health Americas, Inc.

Phone: (585) 338-5306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER