Trial Outcomes & Findings for A Study to Evaluate a New Silicone Hydrogel Contact Lens (NCT NCT01309893)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Baseline & 1 week

Results posted on

2014-11-24

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Investigational Lens First, Then Air Optix Aqua Lens 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.	Air Optix Aqua Lens First, Then Investigational Lens 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.
Week 1 - First Intervention STARTED	33	33
Week 1 - First Intervention COMPLETED	33	33
Week 1 - First Intervention NOT COMPLETED	0	0
Week 2 - Crossover Intervention STARTED	33	33
Week 2 - Crossover Intervention COMPLETED	32	32
Week 2 - Crossover Intervention NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Lens First, Then Air Optix Aqua Lens 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.	Air Optix Aqua Lens First, Then Investigational Lens 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.
Week 2 - Crossover Intervention Lost to Follow-up	1	0
Week 2 - Crossover Intervention Missed crossover visit	0	1

Baseline Characteristics

A Study to Evaluate a New Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=66 Participants All eligible enrolled participants
Age, Continuous	29.6 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline & 1 week

Population: All eligible, dispensed eyes

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

Outcome measures

Outcome measures
Measure	Investigational Lens n=132 eyes Bausch \& Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Air Optix Aqua Lens n=132 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Distance High Contrast logMAR Visual Acuity at 1 Week	-0.031 logMAR Standard Deviation 0.069	-0.015 logMAR Standard Deviation 0.071

SECONDARY outcome

Timeframe: 1 week

Population: All dispensed eyes

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.

Outcome measures

Outcome measures
Measure	Investigational Lens n=130 eyes Bausch \& Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Air Optix Aqua Lens n=126 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Slit Lamp Findings ≥ Grade 2	0 eyes	0 eyes

SECONDARY outcome

Timeframe: 1 week

Population: All eligible dispensed eyes

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

Outcome measures

Outcome measures
Measure	Investigational Lens n=126 eyes Bausch \& Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis for one week	Air Optix Aqua Lens n=126 eyes Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week
Overall Comfort	57.3 units on a scale Standard Deviation 27.8	80.8 units on a scale Standard Deviation 27.2

Adverse Events

Investigational Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air Optix Aqua 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

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