Trial Outcomes & Findings for Safety and Effectiveness of the Qualis Contact Lens (NCT NCT04295499)

NCT ID: NCT04295499

Last Updated: 2023-10-19

Results Overview

The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 91 days
• Results posted on: 2023-10-19

Participant Flow

The enrollment period started in July 2020 and was closed in October 2020 after successfully fulfilling the enrollment goal (75 subjects). Data collection occurred from July 22, 2020 to January 28, 2021.

Participant milestones

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens
Overall Study STARTED	50	25
Overall Study COMPLETED	48	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens
Overall Study moving out of state	1	0
Overall Study traveling overseas for business prior to the study completion	1	0

Baseline Characteristics

Safety and Effectiveness of the Qualis Contact Lens

Baseline characteristics by cohort

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens n=50 Participants Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens n=25 Participants Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Total n=75 Participants Total of all reporting groups
Age, Continuous	26.90 years n=5 Participants	27.32 years n=7 Participants	27.04 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	17 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	25 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 91 days

Population: open-label, multi-center, randomized concurrent-control study with the treatment duration of 91 days. Seventy-five (75) subjects were enrolled in the study-of which 50 subjects wore the test lenses (Qualis (Linofilcon A) Silicone Hydrogel Soft Contact Lens for Daily Wear) and 25 subjects wore the control lenses (Acuvue Vita (senofilcon C) Monthly Contact Lens).

The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.

Outcome measures

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens n=100 eyes Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens n=50 eyes Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens
Number of Eyes With Non-Serious Adverse Reactions Non-ocular adverse events (significant but non-serious)	1 eyes	3 eyes
Number of Eyes With Non-Serious Adverse Reactions Non-device related ocular adverse events (significant but non-serious)	7 eyes	0 eyes
Number of Eyes With Non-Serious Adverse Reactions Device related ocular adverse events (significant but non-serious)	1 eyes	1 eyes

PRIMARY outcome

Timeframe: 91 days

The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better

Outcome measures

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens n=50 Participants Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens n=50 eyes Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens
Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better Initial best corrected contact lens visual acuity with spherical over-refraction	100 eyes	50 eyes
Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better Visual acuity (VA) results -Day91-	96 eyes	47 eyes

Adverse Events

Test Device: Qualis Silicone Hydrogel Soft Contact Lens

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Control Device: Acuvue Vita Monthly Contact Lens

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Device: Qualis Silicone Hydrogel Soft Contact Lens n=50 participants at risk Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens	Control Device: Acuvue Vita Monthly Contact Lens n=25 participants at risk Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens
General disorders Common cold	0.00% 0/50 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	4.0% 1/25 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
General disorders Migraines	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
General disorders Covid-19 positive	0.00% 0/50 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	8.0% 2/25 • Number of events 2 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
Eye disorders Presceptal Cellulitis	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
Eye disorders Internal hordeolum	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
Eye disorders Visual aura	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
Eye disorders papillary conjunctivitis	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
Eye disorders Mild contact dermatitis	2.0% 1/50 • Number of events 1 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.	0.00% 0/25 • through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.

Additional Information

Dr. Jimmy Chou

Unicon Optical Co., Ltd.

Phone: +88635775586

Email: ra@uniconvision.com.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place