Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

• Sponsor: Massachusetts Eye and Ear Infirmary (Other)
• Overall Status: Completed
• CT.gov ID: NCT01250925
• Collaborator: University of Iowa (Other), Alcon Research (Industry)
• Enrollment: 94
• Locations: 2
• Arms: 3
• Duration (Months): 23
• Patients Per Site: 47
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Refractive Error	Drug: ReNu MultiPlus® MultiPurpose Solution; Drug: OPTI-FREE® RepleniSH®; Drug: Clear Care®	Phase 4

Detailed Description

An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OPTI-FREE® RepleniSH® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Drug: OPTI-FREE® RepleniSH®; Contact Lens care regimen
Active Comparator: Clear Care® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Drug: Clear Care®; Contact lens care regimen
Active Comparator: ReNu MultiPlus® MultiPurpose Solution 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Drug: ReNu MultiPlus® MultiPurpose Solution; Contact lens care regimen

Outcome Measures

Primary Outcome Measures

1. Corneal Epithelial Immune Dendritic Cell Density (Central Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

2. Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

3. Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

4. Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

5. Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

6. Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

7. Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

8. Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

9. Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea) [Six weeks]

   The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

10. Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea) [Six weeks]

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

Secondary Outcome Measures

1. Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events [Six weeks]

   The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subjects must be 18 years of age and may be of any race and either gender.

2. Subjects must not have ever worn contact lenses.

3. Subjects must have normal, healthy eyes.

Exclusion Criteria:

1. Subjects must not use additional lens cleaners.

2. subjects must not have any ocular or systemic disease.

3. Subjects must not have history of ocular surgery/trauma within the last 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242-1091
2	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts Eye and Ear Infirmary
• University of Iowa
• Alcon Research

Investigators

• Principal Investigator: Pedram Hamrah, MD, Massachusetts Eye and Ear Infirmary
• Principal Investigator: Christine Sindt, OD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT01250925
• Other Study ID Numbers: 10-04-029
• First Posted: Dec 1, 2010
• Last Update Posted: Jan 10, 2017
• Last Verified: Apr 1, 2013

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Massachusetts Eye and Ear Infirmary: Contact lens; Lens care
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	94 Neophyte contact lens wearers were fitted for one of 3 types of contact lenses (Bausch and Lomb PureVision; Vistakon Acuvue Oasys or Cooper Vision Biofinity) and were then randomized into one of three test articles (care regimens): OptiFree RepleniSH Multi-Purpose Disinfecting Solution, Clear Care or ReNu MultiPlus Multi-Purpose Solution.
Pre-assignment Detail	127 subjects were screened, out of which 94 were successfully enrolled and 35 were screenfailed due to non-normal clinical findings. Of the enrolled, 10 did not complete the study visits.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Period Title: Overall Study
STARTED	31	31	32
COMPLETED	26	28	30
NOT COMPLETED	5	3	2

Baseline Characteristics

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution	Total
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	Total of all reporting groups
Overall Participants	31	31	32	94
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	31 100%	31 100%	32 100%	94 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.7 (10.3)	32.9 (12.2)	30.6 (9.1)	31.4 (10.5)
Gender (Count of Participants)
Female	23 74.2%	18 58.1%	14 43.8%	55 58.5%
Male	8 25.8%	13 41.9%	18 56.3%	39 41.5%
Region of Enrollment (participants) [Number]
United States	31 100%	31 100%	32 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	46.2 (9.4)	44.8 (11.6)	62.3 (12.2)

2. Secondary Outcome

Title	Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
Description	The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the study visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Number [participants]	0 0%	1 3.2%	1 3.1%

3. Primary Outcome

Title	Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the study visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	109.0 (12.2)	90.1 (9.7)	113.6 (9.3)

4. Primary Outcome

Title	Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the study visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	77.7 (8.6)	67.8 (8.1)	73.6 (6.6)

5. Primary Outcome

Title	Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the study visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	106.1 (15.2)	92.5 (9.3)	106.1 (11.3)

6. Primary Outcome

Title	Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the study visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	63.2 (12.2)	59.0 (8.8)	58.7 (5.7)

7. Primary Outcome

Title	Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	0.3 (0.2)	0.4 (0.2)	0.4 (0.2)

8. Primary Outcome

Title	Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	0.4 (0.2)	0.5 (0.2)	0.7 (0.4)

9. Primary Outcome

Title	Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	1.6 (0.9)	1.2 (0.5)	1.1 (0.5)

10. Primary Outcome

Title	Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	0.2 (0.1)	0.6 (0.2)	0.3 (0.2)

11. Primary Outcome

Title	Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
Description	The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Time Frame	Six weeks

Outcome Measure Data

Analysis Population Description

Participants who completed all visits were analyzed.

Arm/Group Title	OPTI-FREE® RepleniSH®	Clear Care®	ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Measure Participants	26	28	30
Measure eyes	52	56	60
Mean (Standard Error) [cells/mm2]	0.4 (0.2)	0.7 (0.3)	0.8 (0.5)

Adverse Events

Time Frame	Six weeks
Arm/Group Title	OPTI-FREE® RepleniSH®		Clear Care®		ReNu MultiPlus® MultiPurpose Solution
Arm/Group Description	33 participants will be assigned to use this lens care regimen during the six-week assessment period		33 participants will be assigned to use this lens care regimen during the six-week assessment period		33 participants will be assigned to use this lens care regimen during the six-week assessment period
All Cause Mortality
	OPTI-FREE® RepleniSH®		Clear Care®		ReNu MultiPlus® MultiPurpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	OPTI-FREE® RepleniSH®		Clear Care®		ReNu MultiPlus® MultiPurpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/31 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	OPTI-FREE® RepleniSH®		Clear Care®		ReNu MultiPlus® MultiPurpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		1/31 (3.2%)		1/32 (3.1%)
Eye disorders
Eye irritation	0/31 (0%)	0	1/31 (3.2%)	1	1/32 (3.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.