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Completed

NCT Number: NCT01494818

Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

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.

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Key information

Conditions

Contact Lens Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria may apply.

Treatment and study plan

Hydrogen peroxide-based contact lens care system

Device

Other names: CLEAR CARE®/AOSEPT Plus

PHMB-containing contact lens solution

Device

Other names: ReNu® MultiPlus Multi-Purpose solution

Soft contact lenses

Device

Contact lenses identical to habitual prescription worn per usual replacement regimen

Primary outcomes

  1. Maximum Papillae

    Time frame: 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.

  2. Maximum Eyelid Hyperaemia

    Time frame: 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.

  3. Upper Lid Redness

    Time frame: 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.

  4. Change From Baseline in Upper Eyelid Margin Staining at Month 3

    Time frame: 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.

Secondary outcomes

  1. Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)

    Time frame: 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.

  2. Protective Index

    Time frame: 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.

  3. Median Front Lens Deposits

    Time frame: 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.

  4. Total Lipid Uptake Per Lens

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2011
Registry last updated
Sep 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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