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

Conditions

Myopia, Refractive Error

Keywords

Contact lens, Lens care

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.

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.

Related papers

No related papers found yet.

Interventions

DRUGReNu MultiPlus® MultiPurpose Solution

Contact lens care regimen

DRUGOPTI-FREE® RepleniSH®

Contact Lens care regimen

DRUGClear Care®

Contact lens care regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

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 details

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.

Participants by arm

Arm	Count
OPTI-FREE® RepleniSH® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	31
Clear Care® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	31
ReNu MultiPlus® MultiPurpose Solution 33 participants will be assigned to use this lens care regimen during the six-week assessment period	32
Total	94

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1
Overall Study	Lost to Follow-up	1	1	0
Overall Study	Physician Decision	0	2	1
Overall Study	Protocol Violation	2	0	0
Overall Study	Withdrawal by Subject	2	0	0

Baseline characteristics

Characteristic	Clear Care®	ReNu MultiPlus® MultiPurpose Solution	OPTI-FREE® RepleniSH®	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	31 Participants	32 Participants	31 Participants	94 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 12.2	30.6 years STANDARD_DEVIATION 9.1	30.7 years STANDARD_DEVIATION 10.3	31.4 years STANDARD_DEVIATION 10.5
Gender Female	18 Participants	14 Participants	23 Participants	55 Participants
Gender Male	13 Participants	18 Participants	8 Participants	39 Participants
Region of Enrollment United States	31 participants	32 participants	31 participants	94 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 31	1 / 31	1 / 32
serious Total, serious adverse events	0 / 31	0 / 31	0 / 32