Trial Outcomes & Findings for Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (NCT NCT01494818)

NCT ID: NCT01494818

Last Updated: 2013-09-27

Results Overview

Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: Baseline, Month 3
• Results posted on: 2013-09-27

Participant Flow

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

Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.

Participant milestones

Measure	CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Study STARTED	39	39
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Overall Study Relocation	1	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

Baseline characteristics by cohort

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	Total n=74 Participants Total of all reporting groups
Age Continuous	34.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	35.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	35.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Maximum Papillae Month 3	2.0 Units on a scale Interval 0.0 to 3.0	2.0 Units on a scale Interval 0.0 to 3.0
Maximum Papillae Baseline (habitual contact lenses and care system)	2.0 Units on a scale Interval 0.0 to 4.0	2.0 Units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Maximum Eyelid Hyperaemia Baseline (habitual contact lenses and care system)	2.0 Units on a scale Interval 1.0 to 4.0	2.0 Units on a scale Interval 1.0 to 4.0
Maximum Eyelid Hyperaemia Month 3	2.0 Units on a scale Interval 1.0 to 3.0	2.0 Units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Upper Lid Redness Month 3	35.2 Percentage of total surface measured Standard Deviation 7.0	35.4 Percentage of total surface measured Standard Deviation 5.8
Upper Lid Redness Baseline (habitual contact lenses and care system)	34.8 Percentage of total surface measured Standard Deviation 6.8	34.9 Percentage of total surface measured Standard Deviation 6.1

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Change From Baseline in Upper Eyelid Margin Staining at Month 3	-0.014 square millimeters Standard Deviation 3.905	-0.754 square millimeters Standard Deviation 4.179

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) Baseline (habitual contact lenses and care system)	4.05 Seconds Standard Deviation 4.63 • Interval 0.9 to 32.0	5.08 Seconds Standard Deviation 4.07 • Interval 1.2 to 16.6
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) Month 3	5.76 Seconds Standard Deviation 4.50 • Interval 1.0 to 24.7	4.22 Seconds Standard Deviation 2.12 • Interval 1.3 to 12.2

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Protective Index Baseline (habitual contact lenses and care system)	95.9 Percent of visible contact lens surface Standard Deviation 11.0	95.8 Percent of visible contact lens surface Standard Deviation 10.2
Protective Index Month 3	96.4 Percent of visible contact lens surface Standard Deviation 10.0	97.8 Percent of visible contact lens surface Standard Deviation 5.8

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Median Front Lens Deposits Baseline (habitual contact lenses and care system)	0 Units on a scale Interval 0.0 to 2.0	0 Units on a scale Interval 0.0 to 1.0
Median Front Lens Deposits Month 3	0 Units on a scale Interval 0.0 to 0.0	0 Units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: All enrolled and dispensed participants who completed the study as per protocol

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 would indicate a cleaner lens surface.

Outcome measures

Measure	CLEAR CARE/AOSEPT Plus n=37 Participants Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=37 Participants PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Total Lipid Uptake Per Lens Baseline (habitual contact lenses and care system)	38.95 micrograms Standard Deviation 23.94 • Interval 4.121 to 95.504	36.44 micrograms Standard Deviation 47.59 • Interval 4.15 to 97.875
Total Lipid Uptake Per Lens Month 3	32.40 micrograms Standard Deviation 24.53	34.20 micrograms Standard Deviation 26.57

Adverse Events

CLEAR CARE/AOSEPT Plus

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

ReNu MultiPlus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CLEAR CARE/AOSEPT Plus n=39 participants at risk Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=39 participants at risk PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Surgical and medical procedures Hysterectomy	2.6% 1/39 • Number of events 1 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.	0.00% 0/39 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.
Skin and subcutaneous tissue disorders Hospitalization	2.6% 1/39 • Number of events 1 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.	0.00% 0/39 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.

Other adverse events

Measure	CLEAR CARE/AOSEPT Plus n=39 participants at risk Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	ReNu MultiPlus n=39 participants at risk PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Eye disorders Toxic reaction to solution	7.7% 3/39 • Number of events 4 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.	0.00% 0/39 • Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product. An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.

Additional Information

Renee Garofalo, OD, FAAO

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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