Trial Outcomes & Findings for Safety and Efficacy of a Contact Lens for Daily Disposable Use (NCT NCT01365039)

NCT ID: NCT01365039

Last Updated: 2014-01-08

Results Overview

Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 173 participants
• Primary outcome timeframe: 4 visits over 3 months
• Results posted on: 2014-01-08

Participant Flow

A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011.

This was a 3 month randomized, parallel, bilateral, single-masked study. One participant discontinued the study.

Participant milestones

Measure	SofLens Lens The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Test Lens Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Overall Study STARTED	86	87
Overall Study COMPLETED	85	87
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	SofLens Lens The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Test Lens Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Overall Study Study related symptoms and complaints	1	0

Baseline Characteristics

Safety and Efficacy of a Contact Lens for Daily Disposable Use

Baseline characteristics by cohort

Measure	SofLens n=86 Participants The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Test Lens n=87 Participants Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Total n=173 Participants Total of all reporting groups
Age, Customized Between 18 and 40 years	86 participants n=93 Participants	87 participants n=4 Participants	173 participants n=27 Participants
Sex: Female, Male Female	64 Participants n=93 Participants	56 Participants n=4 Participants	120 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	31 Participants n=4 Participants	53 Participants n=27 Participants
Region of Enrollment United States	86 participants n=93 Participants	87 participants n=4 Participants	173 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 visits over 3 months

Population: Over All Follow-up Visits, Eyes with Findings \> Grade 2 (All Dispensed Eyes)

Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses

Outcome measures

Measure	SofLens Lens n=172 eyes The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Test Lens n=174 eyes Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Slit Lamp Findings > Grade 2	0 eyes	1 eyes

PRIMARY outcome

Timeframe: 4 visits over 3 months

Population: All Eligible, Dispensed Eyes

Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint

Outcome measures

Measure	SofLens Lens n=172 eyes The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.	Test Lens n=174 eyes Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
High Contrast, Distance logMAR Visual Acuity (VA)	-0.028 logMAR Standard Deviation 0.040	-0.025 logMAR Standard Deviation 0.040

Adverse Events

SofLens Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Steffen, OD, MS

Bausch & Lomb Incorporated

Phone: (585) 338-6399

Email: robert.steffen@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER