Trial Outcomes & Findings for Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface (NCT NCT01250925)

NCT ID: NCT01250925

Last Updated: 2017-01-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 94 participants
• Primary outcome timeframe: Six weeks
• Results posted on: 2017-01-10

Participant Flow

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.

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.

Participant milestones

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

Reasons for withdrawal

Measure	OPTI-FREE® RepleniSH® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	2	0	0
Overall Study Protocol Violation	2	0	0
Overall Study Physician Decision	0	2	1
Overall Study Adverse Event	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	OPTI-FREE® RepleniSH® n=31 Participants 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=31 Participants 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=32 Participants 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	31 Participants n=7 Participants	32 Participants n=5 Participants	94 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	32.9 years STANDARD_DEVIATION 12.2 • n=7 Participants	30.6 years STANDARD_DEVIATION 9.1 • n=5 Participants	31.4 years STANDARD_DEVIATION 10.5 • n=4 Participants
Gender Female	23 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	55 Participants n=4 Participants
Gender Male	8 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	39 Participants n=4 Participants
Region of Enrollment United States	31 participants n=5 Participants	31 participants n=7 Participants	32 participants n=5 Participants	94 participants n=4 Participants

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)	46.2 cells/mm2 Standard Error 9.4	44.8 cells/mm2 Standard Error 11.6	62.3 cells/mm2 Standard Error 12.2

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed the study visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)	109.0 cells/mm2 Standard Error 12.2	90.1 cells/mm2 Standard Error 9.7	113.6 cells/mm2 Standard Error 9.3

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed the study visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)	77.7 cells/mm2 Standard Error 8.6	67.8 cells/mm2 Standard Error 8.1	73.6 cells/mm2 Standard Error 6.6

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed the study visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)	106.1 cells/mm2 Standard Error 15.2	92.5 cells/mm2 Standard Error 9.3	106.1 cells/mm2 Standard Error 11.3

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed the study visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)	63.2 cells/mm2 Standard Error 12.2	59.0 cells/mm2 Standard Error 8.8	58.7 cells/mm2 Standard Error 5.7

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)	0.3 cells/mm2 Standard Error 0.2	0.4 cells/mm2 Standard Error 0.2	0.4 cells/mm2 Standard Error 0.2

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)	0.4 cells/mm2 Standard Error 0.2	0.5 cells/mm2 Standard Error 0.2	0.7 cells/mm2 Standard Error 0.4

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)	1.6 cells/mm2 Standard Error 0.9	1.2 cells/mm2 Standard Error 0.5	1.1 cells/mm2 Standard Error 0.5

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)	0.2 cells/mm2 Standard Error 0.1	0.6 cells/mm2 Standard Error 0.2	0.3 cells/mm2 Standard Error 0.2

PRIMARY outcome

Timeframe: Six weeks

Population: Participants who completed all visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)	0.4 cells/mm2 Standard Error 0.2	0.7 cells/mm2 Standard Error 0.3	0.8 cells/mm2 Standard Error 0.5

SECONDARY outcome

Timeframe: Six weeks

Population: Participants who completed the study visits were analyzed.

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.

Outcome measures

Measure	OPTI-FREE® RepleniSH® n=52 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=56 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=60 eyes 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events	0 participants	1 participants	1 participants

Adverse Events

OPTI-FREE® RepleniSH®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clear Care®

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ReNu MultiPlus® MultiPurpose Solution

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	OPTI-FREE® RepleniSH® n=31 participants at risk 33 participants will be assigned to use this lens care regimen during the six-week assessment period	Clear Care® n=31 participants at risk 33 participants will be assigned to use this lens care regimen during the six-week assessment period	ReNu MultiPlus® MultiPurpose Solution n=32 participants at risk 33 participants will be assigned to use this lens care regimen during the six-week assessment period
Eye disorders Eye irritation	0.00% 0/31 • Six weeks	3.2% 1/31 • Number of events 1 • Six weeks	3.1% 1/32 • Number of events 1 • Six weeks

Additional Information

Dr. Pedram Hamrah

Massachusetts Eye and Ear Infirmary

Phone: 617-573-3313

Email: cornea_research@meei.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60