Trial Outcomes & Findings for Feasibility of a New Silicone Hydrogel Lens (NCT NCT01131130)

Results Overview

Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

7 days

Results posted on

2014-04-30

Participant Flow

There were 120 participants enrolled in this bilateral eye, three-period crossover study at four investigative sites in the United States (US). All participants were adapted wearers of soft contact lenses. The first participant was enrolled in the study on 5/10/2010 and the last participant exited the study on 6/10/2010.

Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Of the 120 participants enrolled 2 were ineligible at baseline and 2 discontinued following dispensing of lenses. 116 participants completed the study.

Participant milestones

Participant milestones
Measure	Over All Study Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
Period 1 - Baseline STARTED	118
Period 1 - Baseline COMPLETED	117
Period 1 - Baseline NOT COMPLETED	1
Period 2 - Crossover STARTED	117
Period 2 - Crossover COMPLETED	117
Period 2 - Crossover NOT COMPLETED	0
Period 3- Crossover STARTED	117
Period 3- Crossover COMPLETED	116
Period 3- Crossover NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Over All Study Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
Period 1 - Baseline Pregnancy	1
Period 3- Crossover + Slit lamp finding	1

Baseline Characteristics

Feasibility of a New Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Over All Study n=117 Participants Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
Age, Continuous	31.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	117 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: All eligible dispensed eyes

Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

Outcome measures

Outcome measures
Measure	Investigational Contact Lens n=230 eyes Bausch \& Lomb Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.	Acuvue Oasys Contact Lens n=232 eyes Johnson \& Johnson Lens Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens	74.3 units on a scale Standard Deviation 22.1	79.4 units on a scale Standard Deviation 22.1

PRIMARY outcome

Timeframe: 7 days

Population: All eligible, dispensed eyes

Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

Outcome measures

Outcome measures
Measure	Investigational Contact Lens n=230 eyes Bausch \& Lomb Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.	Acuvue Oasys Contact Lens n=232 eyes Johnson \& Johnson Lens Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys	74.3 units on a scale Standard Deviation 22.1	88.0 units on a scale Standard Deviation 22.1

SECONDARY outcome

Timeframe: 7 days

Population: All eligible, dispensed eyes

Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).

Outcome measures

Outcome measures
Measure	Investigational Contact Lens n=229 eyes Bausch \& Lomb Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.	Acuvue Oasys Contact Lens n=232 eyes Johnson \& Johnson Lens Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Lens Wettability, Test Lens vs. Acuvue Oasys Slight	14 eyes	16 eyes
Lens Wettability, Test Lens vs. Acuvue Oasys Mild	1 eyes	0 eyes
Lens Wettability, Test Lens vs. Acuvue Oasys Optimal	210 eyes	214 eyes
Lens Wettability, Test Lens vs. Acuvue Oasys Moderate	3 eyes	2 eyes
Lens Wettability, Test Lens vs. Acuvue Oasys Severe	1 eyes	0 eyes

SECONDARY outcome

Timeframe: 7 days

Population: All eligible, dispensed eyes

Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).

Outcome measures

Outcome measures
Measure	Investigational Contact Lens n=229 eyes Bausch \& Lomb Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.	Acuvue Oasys Contact Lens n=231 eyes Johnson \& Johnson Lens Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
Lens Wettability, Test Lens vs. Air Optix Aqua Optimal	210 eyes	219 eyes
Lens Wettability, Test Lens vs. Air Optix Aqua Slight	14 eyes	10 eyes
Lens Wettability, Test Lens vs. Air Optix Aqua Mild	1 eyes	0 eyes
Lens Wettability, Test Lens vs. Air Optix Aqua Moderate	3 eyes	2 eyes
Lens Wettability, Test Lens vs. Air Optix Aqua Severe	1 eyes	0 eyes

Adverse Events

Investigational Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acuvue Oasys Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air Optix Aqua

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