A Study to Evaluate a New Silicone Hydrogel Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01309893
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 32.4

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Investigational Lens; Device: Air Optix Aqua lens	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: Jan 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Lens Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.	Device: Investigational Lens; Lenses worn on a daily wear basis for one week; Device: Air Optix Aqua lens; Lenses worn on a daily wear basis for one week
Active Comparator: Air Optix Aqua Lens Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.	Device: Investigational Lens; Lenses worn on a daily wear basis for one week; Device: Air Optix Aqua lens; Lenses worn on a daily wear basis for one week

Outcome Measures

Primary Outcome Measures

1. Distance High Contrast logMAR Visual Acuity at 1 Week [Baseline & 1 week]

   Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week

Secondary Outcome Measures

1. Slit Lamp Findings ≥ Grade 2 [1 week]

   Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.

2. Overall Comfort [1 week]

   Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.

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 myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria:

• 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	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01309893
• Other Study ID Numbers: 687E
• First Posted: Mar 7, 2011
• Last Update Posted: Nov 24, 2014
• Last Verified: Nov 1, 2014

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

Study Results

Participant Flow

Recruitment Details	Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.
Pre-assignment Detail	66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.

Arm/Group Title	Investigational Lens First, Then Air Optix Aqua Lens	Air Optix Aqua Lens First, Then Investigational Lens
Arm/Group Description	Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.	Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
Period Title: Week 1 - First Intervention
STARTED	33	33
COMPLETED	33	33
NOT COMPLETED	0	0
Period Title: Week 1 - First Intervention
STARTED	33	33
COMPLETED	32	32
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	All eligible enrolled participants
Overall Participants	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.6 (9.4)
Sex: Female, Male (Count of Participants)
Female	52 78.8%
Male	14 21.2%
Region of Enrollment (participants) [Number]
United States	66 100%

Outcome Measures

1. Primary Outcome

Title	Distance High Contrast logMAR Visual Acuity at 1 Week
Description	Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week
Time Frame	Baseline & 1 week

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes

Arm/Group Title	Investigational Lens	Air Optix Aqua Lens
Arm/Group Description	Bausch & Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Measure Participants	66	66
Measure eyes	132	132
Least Squares Mean (Standard Deviation) [logMAR]	-0.031 (0.069)	-0.015 (0.071)

2. Secondary Outcome

Title	Slit Lamp Findings ≥ Grade 2
Description	Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

All dispensed eyes

Arm/Group Title	Investigational Lens	Air Optix Aqua Lens
Arm/Group Description	Bausch & Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Measure Participants	65	63
Measure eyes	130	126
Number [eyes]	0	0

3. Secondary Outcome

Title	Overall Comfort
Description	Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

All eligible dispensed eyes

Arm/Group Title	Investigational Lens	Air Optix Aqua Lens
Arm/Group Description	Bausch & Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Measure Participants	63	63
Measure eyes	126	126
Least Squares Mean (Standard Deviation) [units on a scale]	57.3 (27.8)	80.8 (27.2)

Adverse Events

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