Trial Outcomes & Findings for Clinical Trial of Several Contact Lenses in Extended Wear (NCT NCT00762788)

Results Overview

Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

350 participants

Primary outcome timeframe

52 weeks

Results posted on

2015-06-29

Participant Flow

There were 350 subjects recruited with 314 subjects being dispensed lenses. These 36 subjects were excluded due to failing to meet inclusion criteria.

Participant milestones

Participant milestones
Measure	Senofilcon A Contact Lens ACUVUE OASYS	Lotrafilcon A Contact Lens NIGHT\&DAY	Lotrafilcon B Contact Lens O2Optix	Balafilcon A Contact Lens PureVision	Comfilcon A Contact Lens Biofinity	Etafilcon A Contact Lens ACUVUE 2
Overall Study STARTED	55	58	42	64	43	52
Overall Study COMPLETED	29	21	21	38	30	31
Overall Study NOT COMPLETED	26	37	21	26	13	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A Contact Lens ACUVUE OASYS	Lotrafilcon A Contact Lens NIGHT\&DAY	Lotrafilcon B Contact Lens O2Optix	Balafilcon A Contact Lens PureVision	Comfilcon A Contact Lens Biofinity	Etafilcon A Contact Lens ACUVUE 2
Overall Study Lost to Follow-up	26	37	21	26	13	21

Baseline Characteristics

Clinical Trial of Several Contact Lenses in Extended Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Senofilcon A Contact Lens n=55 Participants ACUVUE OASYS	Lotrafilcon A Contact Lens n=58 Participants NIGHT\&DAY	Lotrafilcon B Contact Lens n=42 Participants O2Optix	Balafilcon A Contact Lens n=64 Participants PureVision	Comfilcon A Contact Lens n=43 Participants Biofinity	Etafilcon A Contact Lens n=52 Participants ACUVUE 2	Total n=314 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	7 Participants n=21 Participants	12 Participants n=10 Participants	69 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	45 Participants n=7 Participants	31 Participants n=5 Participants	49 Participants n=4 Participants	36 Participants n=21 Participants	40 Participants n=10 Participants	245 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	21.1 years STANDARD_DEVIATION 3.2 • n=5 Participants	21.6 years STANDARD_DEVIATION 4.9 • n=7 Participants	19.8 years STANDARD_DEVIATION 1.7 • n=5 Participants	21.0 years STANDARD_DEVIATION 3.7 • n=4 Participants	19.5 years STANDARD_DEVIATION 1.3 • n=21 Participants	20.6 years STANDARD_DEVIATION 3.6 • n=10 Participants	20.7 years STANDARD_DEVIATION 3.4 • n=115 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	31 Participants n=7 Participants	25 Participants n=5 Participants	35 Participants n=4 Participants	25 Participants n=21 Participants	26 Participants n=10 Participants	180 Participants n=115 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	27 Participants n=7 Participants	17 Participants n=5 Participants	29 Participants n=4 Participants	18 Participants n=21 Participants	26 Participants n=10 Participants	134 Participants n=115 Participants
Region of Enrollment India	55 participants n=5 Participants	58 participants n=7 Participants	42 participants n=5 Participants	64 participants n=4 Participants	43 participants n=21 Participants	52 participants n=10 Participants	314 participants n=115 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Subjects who were enrolled and dispensed lenses.

Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

Outcome measures

Outcome measures
Measure	Senofilcon A Contact Lens n=55 Participants ACUVUE OASYS	Lotrafilcon A Contact Lens n=58 Participants NIGHT\&DAY	Lotrafilcon B Contact Lens n=42 Participants O2Optix	Balafilcon A Contact Lens n=64 Participants PureVision	Comfilcon A Contact Lens n=43 Participants Biofinity	Etafilcon A Contact Lens n=52 Participants ACUVUE 2
Incidence of Corneal Infiltrative Events	31 percentage of participants Interval 20.0 to 44.0	16 percentage of participants Interval 8.0 to 27.0	10 percentage of participants Interval 4.0 to 22.0	8 percentage of participants Interval 3.0 to 17.0	33 percentage of participants Interval 20.0 to 47.0	10 percentage of participants Interval 4.0 to 21.0

PRIMARY outcome

Timeframe: 52 weeks

Population: Subjects who were enrolled and dispensed lenses.

Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

Outcome measures

Outcome measures
Measure	Senofilcon A Contact Lens n=55 Participants ACUVUE OASYS	Lotrafilcon A Contact Lens n=58 Participants NIGHT\&DAY	Lotrafilcon B Contact Lens n=42 Participants O2Optix	Balafilcon A Contact Lens n=64 Participants PureVision	Comfilcon A Contact Lens n=43 Participants Biofinity	Etafilcon A Contact Lens n=52 Participants ACUVUE 2
Incidence of Adverse Events	35 percentage of participants Interval 23.0 to 48.0	24 percentage of participants Interval 15.0 to 37.0	19 percentage of participants Interval 10.0 to 33.0	31 percentage of participants Interval 21.0 to 43.0	37 percentage of participants Interval 24.0 to 52.0	12 percentage of participants Interval 5.0 to 23.0

Adverse Events

Senofilcon A Contact Lens

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Lotrafilcon A Contact Lens

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Lotrafilcon B Contact Lens

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Balafilcon A Contact Lens

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Comfilcon A Contact Lens

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Etafilcon A Contact Lens

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Senofilcon A Contact Lens n=55 participants at risk ACUVUE OASYS	Lotrafilcon A Contact Lens n=58 participants at risk NIGHT\&DAY	Lotrafilcon B Contact Lens n=42 participants at risk O2Optix	Balafilcon A Contact Lens n=64 participants at risk PureVision	Comfilcon A Contact Lens n=43 participants at risk Biofinity	Etafilcon A Contact Lens n=52 participants at risk ACUVUE 2
Eye disorders Microbial Keratitis	1.8% 1/55 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/58 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/42 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/64 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	2.3% 1/43 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/52 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.

Other adverse events

Other adverse events
Measure	Senofilcon A Contact Lens n=55 participants at risk ACUVUE OASYS	Lotrafilcon A Contact Lens n=58 participants at risk NIGHT\&DAY	Lotrafilcon B Contact Lens n=42 participants at risk O2Optix	Balafilcon A Contact Lens n=64 participants at risk PureVision	Comfilcon A Contact Lens n=43 participants at risk Biofinity	Etafilcon A Contact Lens n=52 participants at risk ACUVUE 2
Eye disorders CLPU	12.7% 7/55 • Number of events 7 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	3.4% 2/58 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	2.4% 1/42 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	3.1% 2/64 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	18.6% 8/43 • Number of events 12 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/52 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
Eye disorders SIE	18.2% 10/55 • Number of events 11 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	8.6% 5/58 • Number of events 6 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	2.4% 1/42 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.7% 3/64 • Number of events 3 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.7% 2/43 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	9.6% 5/52 • Number of events 5 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
Eye disorders New Corneal Scar	3.6% 2/55 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	5.2% 3/58 • Number of events 4 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.8% 2/42 • Number of events 3 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/64 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	11.6% 5/43 • Number of events 5 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/52 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
Eye disorders Other Significant	3.6% 2/55 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	3.4% 2/58 • Number of events 3 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.8% 2/42 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.7% 3/64 • Number of events 4 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	2.3% 1/43 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/52 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
Eye disorders SLF Grade 2 or Less requiring Treatment	1.8% 1/55 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	1.7% 1/58 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	7.1% 3/42 • Number of events 3 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	15.6% 10/64 • Number of events 12 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	4.7% 2/43 • Number of events 2 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/52 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.
Eye disorders Other Non-significant	9.1% 5/55 • Number of events 7 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	6.9% 4/58 • Number of events 6 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	2.4% 1/42 • Number of events 1 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	7.8% 5/64 • Number of events 6 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	0.00% 0/43 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.	5.8% 3/52 • Number of events 6 Significant Events were defined as events that are usually symptomatic and warrant either temporary or permanent discontinuation of lens wear. Non-significant Events were defined as events that are usually asymptomatic and do not warrant discontinuation of lens wear.

Additional Information

Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist

Vistakon

Phone: 1 904 443-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60