Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01494818
• Collaborator: (none)
• Enrollment: 79
• Arms: 2
• Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Care	Device: Hydrogen peroxide-based contact lens care system; Device: PHMB-containing contact lens solution; Device: Soft contact lenses	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: ReNu® MultiPlus Multi-Purpose solution ; Device: Soft contact lenses; Contact lenses identical to habitual prescription worn per usual replacement regimen

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Principal Investigator: Michel Guillon, PhD, FCOptom, FAAO, CCTI, OTG Research & Consultancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01494818
• Other Study ID Numbers: ID 10-59 / M-11-02
• First Posted: Dec 19, 2011
• Last Update Posted: Sep 27, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Alcon Research: Contact lenses; Contact lens solutions
• Additional relevant MeSH terms: Hydrogen Peroxide; Contact Lens Solutions; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one study center located in the United Kingdom.
Pre-assignment Detail	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.

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Period Title: Overall Study
STARTED	39	39
COMPLETED	37	37
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus	Total
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	Total of all reporting groups
Overall Participants	37	37	74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (9.8)	35.5 (10.5)	35.1 (10.1)
Sex: Female, Male (Count of Participants)
Female	21 56.8%	25 67.6%	46 62.2%
Male	16 43.2%	12 32.4%	28 37.8%

Outcome Measures

1. Primary Outcome

Title	Maximum Papillae
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	2.0	2.0
Month 3	2.0	2.0

2. Primary Outcome

Title	Maximum Eyelid Hyperaemia
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	2.0	2.0
Month 3	2.0	2.0

3. Secondary Outcome

Title	Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	4.05 (4.63)	5.08 (4.07)
Month 3	5.76 (4.50)	4.22 (2.12)

4. Primary Outcome

Title	Upper Lid Redness
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	34.8 (6.8)	34.9 (6.1)
Month 3	35.2 (7.0)	35.4 (5.8)

5. Primary Outcome

Title	Change From Baseline in Upper Eyelid Margin Staining at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Mean (Standard Deviation) [square millimeters]	-0.014 (3.905)	-0.754 (4.179)

6. Secondary Outcome

Title	Protective Index
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	95.9 (11.0)	95.8 (10.2)
Month 3	96.4 (10.0)	97.8 (5.8)

7. Secondary Outcome

Title	Median Front Lens Deposits
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	0	0
Month 3	0	0

8. Secondary Outcome

Title	Total Lipid Uptake Per Lens
Description	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.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

All enrolled and dispensed participants who completed the study as per protocol

Arm/Group Title	CLEAR CARE/AOSEPT Plus	ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months	PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Measure Participants	37	37
Baseline (habitual contact lenses and care system)	38.95 (23.94)	36.44 (47.59)
Month 3	32.40 (24.53)	34.20 (26.57)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product.
Adverse Event Reporting Description	An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.
Arm/Group Title	CLEAR CARE/AOSEPT Plus		ReNu MultiPlus
Arm/Group Description	Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months		PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
All Cause Mortality
	CLEAR CARE/AOSEPT Plus		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CLEAR CARE/AOSEPT Plus		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/39 (5.1%)		0/39 (0%)
Skin and subcutaneous tissue disorders
Hospitalization	1/39 (2.6%)	1	0/39 (0%)	0
Surgical and medical procedures
Hysterectomy	1/39 (2.6%)	1	0/39 (0%)	0
Other (Not Including Serious) Adverse Events
	CLEAR CARE/AOSEPT Plus		ReNu MultiPlus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/39 (7.7%)		0/39 (0%)
Eye disorders
Toxic reaction to solution	3/39 (7.7%)	4	0/39 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.