Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

Evaluation of the Effects of Clear Care/AOSEPT Plus Hydrogen Peroxide Solution on the Eyelid Tissues - Part II: Comparative Evaluation With RENU MPS Over 3 Months of Wear

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01494818

Enrollment

Registered

2011-12-19

Start date

2011-11-30

Completion date

2012-07-31

Last updated

2013-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Lens Care

Keywords

Contact lenses, Contact lens solutions

Brief summary

The purpose of this study was to assess and compare the effect of the repeated usage of two different contact lens care systems (one hydrogen peroxide-based cleaning and disinfecting system, and one polyaminopropyl biguanide (PHMB)-containing multipurpose system) with silicone hydrogel contact lenses worn on a daily wear basis for three months. The specific aspect of interest was the effect on the ocular tissue, in particular the eyelids and their associations with the contact lens surface wettability and surface contamination.

Detailed description

The subjects attended the enrollment visit having worn their habitual silicone hydrogel contact lenses for at least six hours on the day of the visit. The enrollment visit was scheduled so that the subjects' habitual lenses were at least 14 ± 3 days old for the subjects replacing their lenses bi-weekly and at least 30 ± 5 days old for those replacing their lenses monthly.

Interventions

DEVICEHydrogen peroxide-based contact lens care system

DEVICEPHMB-containing contact lens solution

DEVICESoft contact lenses

Contact lenses identical to habitual prescription worn per usual replacement regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Read and understand Participant Information Sheet; * Read, sign, and date Informed Consent; * Successfully wearing silicone hydrogel contact lenses under a frequent replacement (biweekly or monthly) daily wear modality; * Using a PHMB-containing multipurpose contact lens solution; * Symptomatic, as specified in protocol; * Best corrected visual acuity of 6/9 or better in each eye; * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Any known sensitivity or intolerance to the contact lenses or len care products to be used; * Systemic disease/medication which might interfere with contact lens wear or produce dry eye side effects; * Ocular allergies or ocular disease which might interfere with contact lens wear; * Use of any concomitant topical ocular medications during the study period; * Participation in an investigational drug or device study within 30 days of entering the study; * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Upper Eyelid Margin Staining at Month 3	Baseline, Month 3	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.
Maximum Papillae	Baseline, Month 3	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.
Maximum Eyelid Hyperaemia	Baseline, Month 3	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.
Upper Lid Redness	Baseline, Month 3	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.

Secondary

Measure	Time frame	Description
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)	Baseline, Month 3	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.
Protective Index	Baseline, Month 3	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.
Median Front Lens Deposits	Baseline, Month 3	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.
Total Lipid Uptake Per Lens	Baseline, Month 3	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.

Participant flow

Recruitment details

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

Pre-assignment details

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.

Participants by arm

Arm	Count
CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	37
ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	37
Total	74

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0
Overall Study	Relocation	1	2

Baseline characteristics

Characteristic	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus	Total
Age Continuous	34.8 years STANDARD_DEVIATION 9.8	35.5 years STANDARD_DEVIATION 10.5	35.1 years STANDARD_DEVIATION 10.1
Sex: Female, Male Female	21 Participants	25 Participants	46 Participants
Sex: Female, Male Male	16 Participants	12 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 39	0 / 39
serious Total, serious adverse events	2 / 39	0 / 39

Outcome results

Primary

Change From Baseline in Upper Eyelid Margin Staining at Month 3

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.

Time frame: Baseline, Month 3