Central Corneal Swelling With Silicone Hydrogel Materials

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02328937
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 6
• Duration (Months): 5
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.

Condition or Disease	Intervention/Treatment	Phase
Corneal Swelling	Device: etafilcon A; Device: lotrafilcon B; Device: comfilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Daily Wear Central Corneal Swelling With Etafilcon A and 2 Silicone Hydrogel Materials
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A/lotrafilcon B/comfilcon A Subjects that were randomized to receive the etafilcon A lens 1st, the lotrafilcon B lens 2nd and the comfilcon A lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A
Active Comparator: etafilcon A/comfilcon A/lotrafilcon B Subjects that were randomized to receive the etafilcon A lens 1st, the comfilcon A lens 2nd and the lotrafilcon B lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A
Active Comparator: comfilcon A/etafilcon A/lotrafilcon B Subjects that were randomized to receive the comfilcon A lens 1st, the etafilcon A lens 2nd and the lotrafilcon B lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A
Active Comparator: comfilcon A/lotrafilcon B/etafilcon A Subjects that were randomized to receive the comfilcon A lens 1st, the lotrafilcon B lens 2nd and the etafilcon A lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A
Active Comparator: lotrafilcon B/etafilcon A/comfilcon A Subjects that were randomized to receive the lotrafilcon B lens 1st, the etafilcon A lens 2nd and the comfilcon A lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A
Active Comparator: lotrafilcon B/comfilcon A/etafilcon A Subjects that were randomized to receive the lotrafilcon B lens 1st, the comfilcon A lens 2nd and the etafilcon A lens 3rd.	Device: etafilcon A; spherical hydrophilic soft contact lens worn in a daily wear modality; Other Names: Investigational Soft Contact Lens - ; Device: lotrafilcon B; Device: comfilcon A

Outcome Measures

Primary Outcome Measures

1. Central Corneal Swelling [6-8 Hours Post lens insertion]

   Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.

Secondary Outcome Measures

1. Limbal Redness [6-8 hours post lens insertion]

   Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The participant must be at leat 18 years old or older and no greater than 65 years old. Children younger than18 will likely no be able to come back and forth to the clinic during the typical work week as outlined in the above (due to school schedules) and thus not be able to adhere to the protocol.

2. The participant must be a current soft contact lens wearer who routinely wears lenses at least 6-8 hours per day and at least 4 days per week for at least the past 3 months.

3. Refraction suitable for spherical soft contact lens powers between -1.00 and -6.00 D the participant must be correctable to 20/30 or better at distance with both eyes with dispensed contact lenses.

4. The participant must be free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis are not allowed. However, evidence of past CLPU will be allowed so long as no more than 3 such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the participant for subsequent CIE.

5. The participant must be correctable to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.

6. Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively. Corneal curvatures outside this range may be indicative of a disease state, and the participants are not expected to comfortably wear the study lenses.

7. The participant must own or agree to purchase a pair of spectacles that can be worn when lenses are removed, during the washout periods, or in case of ocular discomfort or emergency.

Exclusion Criteria:

1. The participant has worn rigid gas permeable contact lenses within the last 30 days or PMMA lenses within the past 12 months. These lenses can transiently alter the corneal shape and influence the fitting of soft contact lenses or alter endothelial cell morphology.

2. The participant has an immunocompromising disease or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during daily contact lens wear.

3. The participant is taking any medication that in the investigator's opinion will affect ocular physiology or study participation.

4. The participant has an ocular disease or condition such as aphakia, clinically significant corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.

5. The participant is taking any ocular medications. If a participant was previous taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.

6. The participant must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.

7. The participant is currently pregnant or lactating. Participant who become pregnant during the study will be discontinued.

8. An employee or member of the UHCMC Eye Institute or a family member of any study personnel.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cleveland	Ohio	United States	44124

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02328937
• Other Study ID Numbers: CR-5550
• First Posted: Dec 31, 2014
• Last Update Posted: Jun 19, 2018
• Last Verified: Dec 1, 2016

Study Results

Participant Flow

Pre-assignment Detail	A total of 41 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 38 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued while 36 completed all study visits.

Arm/Group Title	Etafilcon A/Lotrafilcon B/Comfilcon A	Etafilcon A/Comfilcon A/Lotrafilcon B	Lotrafilcon B/Etafilcon A/Comfilcon A	Lotrafilcon B/Comfilcon A/Etafilcon A	Comfilcon A/Etafilcon A/Lotrafilcon B	Comfilcon A/Lotrafilcon B/Etafilcon A
Arm/Group Description	Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.	Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.	Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.	Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.	Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
Period Title: Period 1
STARTED	7	6	7	6	6	6
COMPLETED	7	6	7	5	6	6
NOT COMPLETED	0	0	0	1	0	0
Period Title: Period 1
STARTED	7	6	7	5	6	6
COMPLETED	7	6	6	5	6	6
NOT COMPLETED	0	0	1	0	0	0
Period Title: Period 1
STARTED	7	6	6	5	6	6
COMPLETED	7	6	6	5	6	6
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All subjects that were dispensed at least one study lens.
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.9 (8.71)
Sex: Female, Male (Count of Participants)
Female	33 86.8%
Male	5 13.2%
Race/Ethnicity, Customized (participants) [Number]
Asian	9 23.7%
Black or African American	10 26.3%
White	19 50%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Central Corneal Swelling
Description	Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.
Time Frame	6-8 Hours Post lens insertion

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed at least one study lens throughout the duration of the study.

Arm/Group Title	Etafilcon A	Lotrafilcon B	Comfilcon A
Arm/Group Description	Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.	Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.	Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
Measure Participants	37	38	36
Mean (Standard Deviation) [um]	542.2 (31.28)	542.4 (30.69)	544.3 (28.30)

2. Secondary Outcome

Title	Limbal Redness
Description	Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.
Time Frame	6-8 hours post lens insertion

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed at least one study lens throughout the duration of this study.

Arm/Group Title	Etafilcon A	Lotrafilcon B	Comfilcon A
Arm/Group Description	Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.	Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.	Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
Measure Participants	37	38	36
Mean (Standard Deviation) [units on a scale]	6.46 (1.233)	6.24 (1.177)	6.14 (0.977)

Adverse Events

Time Frame	Throughout the entire duration. Approximately 1-week per subject
Arm/Group Title	Etafilcon A		Lotrafilcon B		Comfilcon A
Arm/Group Description	Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.		Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.		Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
All Cause Mortality
	Etafilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A		Lotrafilcon B		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)		0/36 (0%)

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.