Evaluation of a New Silicone Hydrogel Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01309880
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 64.8

Study Details

Study Description

Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Test lens; Device: Air Optix Aqua	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Air Optix Aqua Ciba Vision daily wear contact lens	Device: Air Optix Aqua; Air Optix Aqua contact lens worn on a daily wear basis
Experimental: Test Lens Investigational silicone hydrogel contact lens	Device: Test lens; Investigational silicone hydrogel contact lens worn on a daily wear basis

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Dispensing & 1-week follow up]

   Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.

Secondary Outcome Measures

1. Slit Lamp Findings [1 week]

   Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.

2. Comfort [1 Weeks]

   At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.

• Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

• Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.

• Any systemic disease affecting ocular health.

• Using any systemic or topical medications that will affect ocular physiology or lens performance.

• An active ocular disease, any corneal infiltrative response or are using any ocular medications.

• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

• Allergic to any component in the study care products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb, Incorporated	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Beverly Barna, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01309880
• Other Study ID Numbers: 686E
• First Posted: Mar 7, 2011
• Last Update Posted: Feb 23, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Bausch & Lomb Incorporated: Contact lens
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	This study was a randomized, bilateral, subject-masked, two-week study with a crossover at one week, conducted at three sites in the United States (US). First participant was enrolled on 12/01/2010, last participant exited the study on 12/23/2010.
Pre-assignment Detail	A total of 66 participants (132 eyes) were enrolled in the study. One-half (33) were randomized to receive the investigational RD2117-01 ID4 contact lens first, and the other half (33) was randomized to receive the Air Optix Aqua contact lens first then crossed over after 1 week. All participants completed the study.

Arm/Group Title	Air Optix Aqua Then Test Lens	Test Lens Then Air Optix Aqua
Arm/Group Description	Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.	The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
Period Title: Overall Study
STARTED	33	33
COMPLETED	33	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
Overall Participants	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (9.6)
Sex: Female, Male (Count of Participants)
Female	47 71.2%
Male	19 28.8%
Region of Enrollment (participants) [Number]
United States	66 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
Time Frame	Dispensing & 1-week follow up

Outcome Measure Data

Analysis Population Description

All Eligible, Dispensed Eyes

Arm/Group Title	Air Optix Aqua	Test Lens
Arm/Group Description	Ciba Vision daily wear contact lens Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis	Investigational silicone hydrogel contact lens Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
Measure Participants	66	66
Measure eyes	132	132
Dispensing	-0.083 (0.071)	-0.085 (0.071)
1-Week Follow-up	-0.084 (0.077)	-0.078 (0.077)

2. Secondary Outcome

Title	Slit Lamp Findings
Description	Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

All Dispensed Eyes

Arm/Group Title	Air Optix Aqua	Test Lens
Arm/Group Description	Ciba Vision daily wear contact lens Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis	Investigational silicone hydrogel contact lens Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
Measure Participants	66	66
Measure eyes	132	132
Grade 0	46	82
Grade 1	86	50
Grade 2	0	0
> Grade 2	0	0

3. Secondary Outcome

Title	Comfort
Description	At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.
Time Frame	1 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Air Optix Aqua	Test Lens
Arm/Group Description	Ciba Vision daily wear contact lens Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis	Investigational silicone hydrogel contact lens Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
Measure Participants	66	66
Measure eyes	132	132
Least Squares Mean (Standard Deviation) [units on a scale]	85.5 (19.5)	81.8 (19.5)

Adverse Events

Time Frame	1 week
Arm/Group Title	Air Optix Aqua		Test Lens
Arm/Group Description	Ciba Vision daily wear contact lens Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis		Investigational silicone hydrogel contact lens Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis
All Cause Mortality
	Air Optix Aqua		Test Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Air Optix Aqua		Test Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Air Optix Aqua		Test Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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