Trial Outcomes & Findings for Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens (NCT NCT02354924)

NCT ID: NCT02354924

Last Updated: 2017-04-14

Results Overview

Visual acuity correctable to snellen 20/25 or better

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-04-14

Participant Flow

Participant milestones

Measure	Visco Soft Contact Lens Olifilcon A, Daily wear, monthly disposable soft contact lens Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Biofinity Soft Contact Lens Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Overall Study STARTED	40	20
Overall Study COMPLETED	40	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Baseline characteristics by cohort

Measure	Visco Soft Contact Lens n=40 Participants Olifilcon A, Daily wear, monthly disposable soft contact lens Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Biofinity Soft Contact Lens n=20 Participants Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.15 years STANDARD_DEVIATION 6.44 • n=5 Participants	36.30 years STANDARD_DEVIATION 5.53 • n=7 Participants	34.87 years STANDARD_DEVIATION 6.13 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	17 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Taiwan	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Visual acuity correctable to snellen 20/25 or better

Outcome measures

Measure	Visco Soft Contact Lens n=80 eye Olifilcon A, Daily wear, monthly disposable soft contact lens Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Biofinity Soft Contact Lens n=40 eye Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Visual Acuity	80 eye	40 eye

SECONDARY outcome

Timeframe: 3 month

Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings

Outcome measures

Measure	Visco Soft Contact Lens n=80 eye Olifilcon A, Daily wear, monthly disposable soft contact lens Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Biofinity Soft Contact Lens n=40 eye Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Slit Lamp Findings	0 eye	0 eye

SECONDARY outcome

Timeframe: 3 month

Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye

Outcome measures

Measure	Visco Soft Contact Lens n=80 eye Olifilcon A, Daily wear, monthly disposable soft contact lens Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.	Biofinity Soft Contact Lens n=40 eye Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Symptoms, Problems and Complaints and Incidence Rate	0 eye	0 eye

Adverse Events

Visco Soft Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofinity Soft Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Huey-Chuan Cheng

Mackay Memorial Hospital_Taipei

Phone: 886-2-25433535

Email: hccheng@ms2.mmh.org.tw

Results disclosure agreements

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