A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00784641
• Collaborator: (none)
• Enrollment: 567
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 282.9

Study Details

Study Description

Brief Summary

Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Novel Bausch & Lomb daily disposable contact lenses; Device: Bausch & Lomb SofLens daily disposable contact lenses.; Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 567 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novel Bausch & Lomb Contact Lens Novel Bausch & Lomb daily disposable contact lenses	Device: Novel Bausch & Lomb daily disposable contact lenses; Lenses to be worn and replaced daily for 2 weeks.
Active Comparator: SofLens Bausch & Lomb SofLens daily disposable contact lenses	Device: Bausch & Lomb SofLens daily disposable contact lenses.; Lenses to be worn and replaced daily for 2 weeks.
Active Comparator: Acuvue Johnson and Johnson 1-Day Acuvue Moist contact lenses	Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses; Lenses to be worn and replaced daily for 2 weeks.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey [At dispensing]

   The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.

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

• Subjects must be myopic and require lens correction in both eyes.

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 wearing monovision, multifocal or toric contact lenses.

• Subjects with grade 2 or greater slit lamp findings.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. James Ferrari	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Bev Barna, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00784641
• Other Study ID Numbers: 496
• First Posted: Nov 4, 2008
• Last Update Posted: Oct 6, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	There were 567 participants enrolled (1134 eyes).

Arm/Group Title	Novel Bausch & Lomb Contact Lens	SofLens	Acuvue
Arm/Group Description	Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.
Period Title: Overall Study
STARTED	189	189	189
COMPLETED	183	186	187
NOT COMPLETED	6	3	2

Baseline Characteristics

Arm/Group Title	Novel Bausch & Lomb Contact Lens	SofLens	Acuvue	Total
Arm/Group Description	Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.	Total of all reporting groups
Overall Participants	188	186	187	561
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	32.8	32.5	32.5	32.6
Sex: Female, Male (Count of Participants)
Female	147 78.2%	136 73.1%	137 73.3%	420 74.9%
Male	41 21.8%	50 26.9%	50 26.7%	141 25.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
Description	The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Time Frame	At dispensing

Outcome Measure Data

Analysis Population Description

Eyes that were dispensed contact lenses are included in the analysis population.

Arm/Group Title	Novel Bausch & Lomb Contact Lens	SofLens	Acuvue
Arm/Group Description	Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.
Measure Participants	188	186	187
Measure eyes	376	372	374
Lens handling upon insertion	340	293	326
Burning/stinging upon insertion	363	333	339
Comfort	333	289	354
Vision	324	338	363

Adverse Events

Time Frame	2 weeks
Adverse Event Reporting Description	Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 378 eyes dispensed the test lens, 376 eyes dispensed the SofLens, and 378 eyes dispensed the Acuvue lens, assessed for adverse events.
Arm/Group Title	Novel Bausch & Lomb Contact Lens		SofLens		Acuvue
Arm/Group Description	Novel Bausch & Lomb daily disposable contact lenses Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.		Bausch & Lomb SofLens daily disposable contact lenses Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.		Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.
All Cause Mortality
	Novel Bausch & Lomb Contact Lens		SofLens		Acuvue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Novel Bausch & Lomb Contact Lens		SofLens		Acuvue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/189 (0%)		0/188 (0%)		0/189 (0%)
Other (Not Including Serious) Adverse Events
	Novel Bausch & Lomb Contact Lens		SofLens		Acuvue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/189 (0%)		0/188 (0%)		0/189 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.