Feasibility of a New Silicone Hydrogel Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01131130
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 117.8

Study Details

Study Description

Brief Summary

The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Investigational contact lens; Device: Acuvue Oasys Contact Lens; Device: Air Optix Aqua	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational contact lens Bausch & Lomb	Device: 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.
Active Comparator: Acuvue Oasys Contact Lens Johnson & Johnson Lens	Device: 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.
Active Comparator: Air Optix Aqua Ciba Vision	Device: Air Optix Aqua; 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.

Outcome Measures

Primary Outcome Measures

1. Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens [7 days]

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

2. Comfort Throughout the Day - Test Lens vs. Acuvue Oasys [7 days]

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

Secondary Outcome Measures

1. Lens Wettability, Test Lens vs. Acuvue Oasys [7 days]

   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).

2. Lens Wettability, Test Lens vs. Air Optix Aqua [7 days]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

• Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria:

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

• Participants with any systemic disease affecting ocular health.

• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Participants with an active ocular disease or are using any ocular medication.

• Participants who have had any corneal surgery (eg, refractive surgery).

• Participants who are allergic to any component in the study care products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Gerard Carains, MCOptom, PhD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01131130
• Other Study ID Numbers: 655
• First Posted: May 26, 2010
• Last Update Posted: Apr 30, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Bausch & Lomb Incorporated: Contact lens
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Over All Study
Arm/Group Description	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 Title: Period 1 - Baseline
STARTED	118
COMPLETED	117
NOT COMPLETED	1
Period Title: Period 1 - Baseline
STARTED	117
COMPLETED	117
NOT COMPLETED	0
Period Title: Period 1 - Baseline
STARTED	117
COMPLETED	116
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Over All Study
Arm/Group Description	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.
Overall Participants	117
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.3 (8.5)
Sex: Female, Male (Count of Participants)
Female	86 73.5%
Male	31 26.5%
Region of Enrollment (participants) [Number]
United States	117 100%

Outcome Measures

1. Secondary Outcome

Title	Lens Wettability, Test Lens vs. Acuvue Oasys
Description	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).
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes

Arm/Group Title	Investigational Contact Lens	Acuvue Oasys Contact Lens
Arm/Group Description	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.	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.
Measure Participants	115	116
Measure eyes	229	232
Optimal	210	214
Slight	14	16
Mild	1	0
Moderate	3	2
Severe	1	0

2. Primary Outcome

Title	Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens
Description	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

All eligible dispensed eyes

Arm/Group Title	Investigational Contact Lens	Air Optix Aqua
Arm/Group Description	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.	Ciba Vision Air Optix Aqua: 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.
Measure Participants	115	116
Measure eyes	230	232
Least Squares Mean (Standard Deviation) [units on a scale]	74.3 (22.1)	79.4 (22.1)

3. Primary Outcome

Title	Comfort Throughout the Day - Test Lens vs. Acuvue Oasys
Description	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes

Arm/Group Title	Investigational Contact Lens	Acuvue Oasys Contact Lens
Arm/Group Description	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.	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.
Measure Participants	115	116
Measure eyes	230	232
Least Squares Mean (Standard Deviation) [units on a scale]	74.3 (22.1)	88.0 (22.1)

4. Secondary Outcome

Title	Lens Wettability, Test Lens vs. Air Optix Aqua
Description	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).
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes

Arm/Group Title	Investigational Contact Lens	Air Optix Aqua
Arm/Group Description	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.	Ciba Vision Air Optix Aqua: 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.
Measure Participants	115	116
Measure eyes	229	231
Optimal	210	219
Slight	14	10
Mild	1	0
Moderate	3	2
Severe	1	0

Adverse Events

Time Frame	7 Days
Arm/Group Title	Investigational Contact Lens		Acuvue Oasys Contact Lens		Air Optix Aqua
Arm/Group Description	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.		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.		Ciba Vision Air Optix Aqua: 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.
All Cause Mortality
	Investigational Contact Lens		Acuvue Oasys Contact Lens		Air Optix Aqua
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Investigational Contact Lens		Acuvue Oasys Contact Lens		Air Optix Aqua
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/117 (0%)		0/117 (0%)		0/117 (0%)
Other (Not Including Serious) Adverse Events
	Investigational Contact Lens		Acuvue Oasys Contact Lens		Air Optix Aqua
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/117 (0%)		0/117 (0%)		0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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