Trial Outcomes & Findings for Product Feasibility of a New Silicone Hydrogel Contact Lens (NCT NCT01309100)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

144 participants

Primary outcome timeframe

1 week

Results posted on

2014-04-29

Participant Flow

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.

144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.

Participant milestones

Participant milestones
Measure	Overall Study 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 Study STARTED	144
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study 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 Study Protocol Violation	1
Overall Study Positive Slit lamp finding	1

Baseline Characteristics

Product Feasibility of a New Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=144 Participants 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.
Age, Continuous	30.6 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Region of Enrollment United States	144 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: All eligible, dispensed eyes

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

Outcome measures

Outcome measures
Measure	Investigational Lens n=286 eyes Bausch \& Lomb investigational silicone hydrogel lens (RD2117-01). Investigational Lens: Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Air Optix Aqua Lens n=286 eyes 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.
Visual Acuity (Investigational vs Air Optix Aqua Lens) Baseline	-0.050 LogMAR Standard Deviation 0.116	-0.060 LogMAR Standard Deviation 0.116
Visual Acuity (Investigational vs Air Optix Aqua Lens) 1 Week follow-up	-0.034 LogMAR Standard Deviation 0.111	-0.039 LogMAR Standard Deviation 0.111

PRIMARY outcome

Timeframe: 1 week

Population: All eligible, dispensed eyes

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

Outcome measures

Outcome measures
Measure	Investigational Lens n=286 eyes Bausch \& Lomb investigational silicone hydrogel lens (RD2117-01). Investigational Lens: Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Air Optix Aqua Lens n=286 eyes 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.
Visual Acuity (Investigational vs Acuvue Oasys Lens) Baseline	-0.050 LogMAR Standard Deviation 0.113	-0.048 LogMAR Standard Deviation 0.113
Visual Acuity (Investigational vs Acuvue Oasys Lens) 1-week follow-up	-0.034 LogMAR Standard Deviation 0.109	-0.033 LogMAR Standard Deviation 0.109

SECONDARY outcome

Timeframe: 1 week

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

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.

Outcome measures

Outcome measures
Measure	Investigational Lens n=286 eyes Bausch \& Lomb investigational silicone hydrogel lens (RD2117-01). Investigational Lens: Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Air Optix Aqua Lens n=286 eyes 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.
Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)	80.9 units on a scale Standard Deviation 21.4	86.5 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: 1 week

Population: All eligible, dispensed eyes

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.

Outcome measures

Outcome measures
Measure	Investigational Lens n=286 eyes Bausch \& Lomb investigational silicone hydrogel lens (RD2117-01). Investigational Lens: Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.	Air Optix Aqua Lens n=284 eyes 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.
Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)	80.9 units on a scale Standard Deviation 21.4	82.1 units on a scale Standard Deviation 21.4

Adverse Events

Overall Study

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

Dr. Robert Steffen

Bausch & Lomb

Phone: 585 338 6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER