Trial Outcomes & Findings for Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems (NCT NCT01699750)

Results Overview

The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

Day 30

Results posted on

2014-12-08

Participant Flow

Participants were recruited from 1 study center located in the United Kingdom.

Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).

Participant milestones

Participant milestones
Measure	Air Optix Aqua Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Overall Study STARTED	34	36
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Air Optix Aqua Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Overall Study Withdrew Consent	0	1
Overall Study Other	0	2

Baseline Characteristics

Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=36 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	Total n=70 Participants Total of all reporting groups
Age, Continuous	36.0 years STANDARD_DEVIATION 10.95 • n=5 Participants	35.3 years STANDARD_DEVIATION 8.77 • n=7 Participants	35.6 years STANDARD_DEVIATION 9.82 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys BIOTRUE with senofilcon A contact lenses for 30 days
Mean Ex-Vivo Total Lipid Uptake Per Lens	7.198 micrograms Standard Deviation 1.5014	35.879 micrograms Standard Deviation 1.8185	—	—

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys BIOTRUE with senofilcon A contact lenses for 30 days
Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)	3.316 seconds Standard Deviation 2.6913	2.918 seconds Standard Deviation 2.4859	—	—

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.

Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys BIOTRUE with senofilcon A contact lenses for 30 days
LogMAR Time-Controlled Visual Acuity (TCVA) High Contrast	0.38 VA unit Standard Deviation 1.058	-0.14 VA unit Standard Deviation 0.999	—	—
LogMAR Time-Controlled Visual Acuity (TCVA) Low Contrast	-1.15 VA unit Standard Deviation 1.213	-1.60 VA unit Standard Deviation 1.040	—	—

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.

The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua n=34 Participants BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys n=33 Participants BIOTRUE with senofilcon A contact lenses for 30 days
Overall Comfort Measured With Visual Analog Scale (VAS)	77.1 units on a scale Standard Deviation 20.25	81.1 units on a scale Standard Deviation 20.37	74.9 units on a scale Standard Deviation 28.43	82.2 units on a scale Standard Deviation 20.76

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.

The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua n=34 Participants BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys n=33 Participants BIOTRUE with senofilcon A contact lenses for 30 days
Overall Dryness Measured With Visual Analog Scale (VAS)	21.8 units on a scale Standard Deviation 20.41	22.2 units on a scale Standard Deviation 22.15	23.3 units on a scale Standard Deviation 25.65	22.5 units on a scale Standard Deviation 25.60

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys BIOTRUE with senofilcon A contact lenses for 30 days
Average Exposure Speed	0.059 percent of area exposed/second Standard Deviation 15.1175	0.105 percent of area exposed/second Standard Deviation 24.4808	—	—

SECONDARY outcome

Timeframe: Day 30

Population: This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.

Outcome measures

Outcome measures
Measure	Air Optix Aqua n=34 Participants Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Acuvue Oasys n=33 Participants Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	BIOTRUE With Air Optix Aqua BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE With Acuvue Oasys BIOTRUE with senofilcon A contact lenses for 30 days
Minimum Protected Area	90.75 percentage of lens surface covered Standard Deviation 15.990	77.79 percentage of lens surface covered Standard Deviation 31.547	—	—

Adverse Events

AIR OPTIX AQUA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ACUVUE OASYS With HYDRACLEAR

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AIR OPTIX AQUA n=34 participants at risk Lotrafilcon B contact lenses worn for 60 days, replaced monthly	ACUVUE OASYS With HYDRACLEAR n=36 participants at risk Senofilcon A contact lenses worn for 60 days, replaced biweekly
Infections and infestations Nasopharyngitis	8.8% 3/34 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.	8.3% 3/36 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/34 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.	5.6% 2/36 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
General disorders Eye complication associated with device	0.00% 0/34 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.	8.3% 3/36 • Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study. An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.

Additional Information

Jessie Lemp, DrPH

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER