Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01494818
First received: December 15, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Contact Lens Care
Device: Hydrogen peroxide-based contact lens care system
Device: PHMB-containing contact lens solution
Device: Soft contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Maximum Papillae [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Upper Eyelid Margin Staining at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT) [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 79
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLEAR CARE/AOSEPT Plus
Hydrogen peroxide-based contact lens care system used per manufacturer's instructions
Device: Hydrogen peroxide-based contact lens care system
Other Name: CLEAR CARE®/AOSEPT Plus
Device: Soft contact lenses
Contact lenses identical to habitual prescription worn per usual replacement regimen
Active Comparator: ReNu MultiPlus
PHMB-containing contact lens solution used per manufacturer's instructions
Device: PHMB-containing contact lens solution
Other Name: ReNu® MultiPlus Multi-Purpose solution
Device: Soft contact lenses
Contact lenses identical to habitual prescription worn per usual replacement regimen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494818

Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI OTG Research & Consultancy
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494818     History of Changes
Other Study ID Numbers: ID 10-59 / M-11-02
Study First Received: December 15, 2011
Results First Received: July 30, 2013
Last Updated: July 30, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
Contact lenses
Contact lens solutions

Additional relevant MeSH terms:
Hydrogen Peroxide
Pharmaceutical Solutions
Contact Lens Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on August 18, 2014