Product Feasibility of a New Silicone Hydrogel Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01309100
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 71.9

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 lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Investigational Lens; Device: Acuvue Oasys Lens; Device: Air Optix Aqua Lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 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: Nov 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Acuity (Investigational vs Air Optix Aqua Lens) [1 week]

   The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

2. Visual Acuity (Investigational vs Acuvue Oasys Lens) [1 week]

   The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.

Secondary Outcome Measures

1. Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) [1 week]

   The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.

2. Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) [1 week]

   The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured 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:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

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

• Subjects must be myopic and require lens correction

Exclusion Criteria:

• Subjects with any systemic disease affecting ocular health.

• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Subjects with an active ocular disease or are using any ocular medication.

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

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

• Principal Investigator: Tara Vaz, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01309100
• Other Study ID Numbers: 672E
• First Posted: Mar 4, 2011
• Last Update Posted: Apr 29, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.
Pre-assignment Detail	144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.

Arm/Group Title	Overall Study
Arm/Group Description	Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
Period Title: Overall Study
STARTED	144
COMPLETED	142
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
Overall Participants	144
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.6 (8.7)
Sex: Female, Male (Count of Participants)
Female	96 66.7%
Male	48 33.3%
Region of Enrollment (participants) [Number]
United States	144 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity (Investigational vs Air Optix Aqua Lens)
Description	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
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 lens (RD2117-01). Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Ciba Vision Air Optix Aqua contact lens. Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
Measure Participants	143	143
Measure eyes	286	286
Baseline	-0.050 (0.116)	-0.060 (0.116)
1 Week follow-up	-0.034 (0.111)	-0.039 (0.111)

2. Secondary Outcome

Title	Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)
Description	The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

1-Week Follow-up, All Eligible, Dispensed Eyes

Arm/Group Title	Investigational Lens	Acuvue Oasys Lens
Arm/Group Description	Bausch & Lomb investigational silicone hydrogel lens(RD2117-01). Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Johnson & Johnson Acuvue Oasys contact lens. Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
Measure Participants	143	143
Measure eyes	286	286
Least Squares Mean (Standard Deviation) [units on a scale]	80.9 (21.4)	86.5 (21.4)

3. Primary Outcome

Title	Visual Acuity (Investigational vs Acuvue Oasys Lens)
Description	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes

Arm/Group Title	Investigational Lens	Acuvue Oasys Lens
Arm/Group Description	Bausch & Lomb investigational silicone hydrogel lens(RD2117-01). Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Johnson & Johnson Acuvue Oasys contact lens. Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
Measure Participants	143	143
Measure eyes	286	286
Baseline	-0.050 (0.113)	-0.048 (0.113)
1-week follow-up	-0.034 (0.109)	-0.033 (0.109)

4. Secondary Outcome

Title	Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)
Description	The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
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 lens(RD2117-01). Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Ciba Vision Air Optix Aqua contact lens. Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
Measure Participants	143	142
Measure eyes	286	284
Least Squares Mean (Standard Deviation) [units on a scale]	80.9 (21.4)	82.1 (21.4)

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Overall Study
Arm/Group Description	Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
All Cause Mortality
	Overall Study
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	0/144 (0%)
Other (Not Including Serious) Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	0/144 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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