An 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 III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594294

Acronym

ID11-56

Enrollment

100

Registered

2012-05-09

Start date

2012-04-30

Completion date

2013-06-30

Last updated

2014-07-25

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

Conditions

Myopia

Keywords

CLEAR CARE®, AOSEPT® Plus, ReNu MultiPlus®, silicone hydrogel, hydrogel, ACUVUE® 2®, AIR OPTIX® AQUA, eyelid response, wettability, contamination, contact lenses

Brief summary

The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.

Detailed description

This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.

Interventions

DEVICECOMPLETE® MPS Easy Rub® Formula contact lens solution

PHMB 0.0001% and poloxamer 0.05% multipurpose solution

DEVICEAOSEPT® Plus contact lens solution

Hydrogen peroxide-based cleaning and disinfection system

DEVICEReNu MultiPlus® contact lens solution

Polyaminopropyl biguanide (PHMB) preserved multipurpose solution

DEVICEEtafilcon A contact lenses

Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.

DEVICELotrafilcon B contact lenses

Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.

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 the Participant Information Sheet; * Read, sign, and date an Informed Consent; * Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality; * Classified as symptomatic according to protocol-specified criteria; * Agree to wear study contact lenses as directed for the duration of the study; * Best corrected visual acuity (BCVA) of 6/9 or better in each eye; * Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used; * Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses); * History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study; * Systemic disease or use of 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 or data and information obtained in this study; * Active ocular infection; * Use of any concomitant topical ocular medications during the study period; * Significant ocular anomaly; * Previous ocular surgery; * History of recent, significant changes in visual acuity; * Any medical condition that might be prejudicial to the study; * Pregnant, planning to be become pregnant, or lactating at time of enrollment; * Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes; * Participation in an investigational drug or device study within 30 days of entering study; * Other protocol-defined

Design outcomes

Primary

Measure	Time frame	Description
Maximum Papillae	Baseline (Day 0), 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. Contact lenses were not worn for this assessment.
Maximum Eyelid Hyperaemia	Baseline (Day 0), 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. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Redness	Baseline (Day 0), Month 3	The contact lenses were removed and upper eyelid 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. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Margin Staining	Baseline (Day 0), 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. Contact lenses were not worn for this assessment.

Secondary

Measure	Time frame	Description
Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)	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. Contact lenses were on-eye for this assessment.

Participant flow

Pre-assignment details

Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).

Participants by arm

Arm	Count
AOSEPT Plus AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)	35
ReNu MultiPlus ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)	36
Total	71

Baseline characteristics

Characteristic	AOSEPT Plus	ReNu MultiPlus	Total
Age, Continuous	35.7 years STANDARD_DEVIATION 11.1	37.1 years STANDARD_DEVIATION 10.7	36.4 years STANDARD_DEVIATION 10.9
Sex: Female, Male Female	21 Participants	25 Participants	46 Participants
Sex: Female, Male Male	14 Participants	11 Participants	25 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	2 / 39

Outcome results

Primary

Maximum Eyelid Hyperaemia

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. Contact lenses were not worn for this assessment.

Time frame: Baseline (Day 0), Month 3