Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

NCT01494818 | Completed Results

• 1 other identifier: ID 10-59 / M-11-02
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contact Lens Care

Keywords

Contact lenses; Contact lens solutions

Outcome Measures

Primary Outcomes (4)

• Maximum Papillae

  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.

  Baseline, Month 3

• 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.

  Baseline, Month 3

• Upper Lid Redness

  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.

  Baseline, Month 3

• 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.

  Baseline, Month 3

Secondary Outcomes (4)

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

  Baseline, Month 3

• Protective Index

  Baseline, Month 3

• Median Front Lens Deposits

  Baseline, Month 3

• Total Lipid Uptake Per Lens

  Baseline, Month 3

Study Arms (2)

CLEAR CARE/AOSEPT Plus

EXPERIMENTAL

Hydrogen peroxide-based contact lens care system used per manufacturer's instructions

Device: Hydrogen peroxide-based contact lens care system; Device: Soft contact lenses

ReNu MultiPlus

ACTIVE COMPARATOR

PHMB-containing contact lens solution used per manufacturer's instructions

Device: PHMB-containing contact lens solution; Device: Soft contact lenses

Interventions

Hydrogen peroxide-based contact lens care system DEVICE

Also known as: CLEAR CARE®/AOSEPT Plus

CLEAR CARE/AOSEPT Plus

PHMB-containing contact lens solution DEVICE

Also known as: ReNu® MultiPlus Multi-Purpose solution

ReNu MultiPlus

Soft contact lenses DEVICE

Contact lenses identical to habitual prescription worn per usual replacement regimen

CLEAR CARE/AOSEPT Plus; ReNu MultiPlus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Interventions

Contact Lenses, Hydrophilic

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Renee Garofalo, OD, FAAO
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Michel Guillon, PhD, FCOptom, FAAO, CCTI

  OTG Research & Consultancy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 27, 2013
• Results First Posted: September 27, 2013

Record last verified: 2013-07