Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01293240
• Collaborator: (none)
• Enrollment: 117
• Arm: 1
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Presbyopia	Device: lotrafilcon B contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lotrafilcon B	Device: lotrafilcon B contact lens; Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.; Other Names: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL

Outcome Measures

Primary Outcome Measures

1. Overall Comfort [2 weeks]

   Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

2. Overall Comfort [4 weeks]

   Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

3. End of Day Dryness [2 weeks]

   End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

4. End of Day Dryness [4 weeks]

   End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

5. Ocular Redness [2 weeks]

   Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

6. Ocular Redness [4 weeks]

   Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

7. Visual Clarity [2 weeks]

   Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

8. Visual Clarity [4 weeks]

   Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

9. Lens Deposits [2 weeks]

   Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

10. Lens Deposits [4 weeks]

    Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

11. Corrected Visual Acuity [2 weeks]

    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

12. Corrected Visual Acuity [4 weeks]

    Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.

• Good general health.

• Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.

• Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.

• Administration of any investigational drug or device within 14 days of study initiation.

• Use of any eye drops with a pharmacological effect within 7 days of Visit 1.

• Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.

• Post-refractive surgery.

• Currently pregnant or lactating by case history.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CIBA VISION

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01293240
• Other Study ID Numbers: P-368-C-400
• First Posted: Feb 10, 2011
• Last Update Posted: Jul 10, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Astigmatism; Presbyopia

Study Results

Participant Flow

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Period Title: Overall Study
STARTED	117
COMPLETED	115
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Overall Participants	117
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.8 (12.6)
Gender (participants) [Number]
Female	79 67.5%
Male	36 30.8%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort
Description	Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	8.6 (1.4)

2. Primary Outcome

Title	Overall Comfort
Description	Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	8.1 (1.7)

3. Primary Outcome

Title	End of Day Dryness
Description	End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	7.4 (2.1)

4. Primary Outcome

Title	End of Day Dryness
Description	End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	7.0 (2.4)

5. Primary Outcome

Title	Ocular Redness
Description	Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	9.1 (1.4)

6. Primary Outcome

Title	Ocular Redness
Description	Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	9.0 (1.6)

7. Primary Outcome

Title	Visual Clarity
Description	Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	8.4 (1.5)

8. Primary Outcome

Title	Visual Clarity
Description	Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Mean (Standard Deviation) [Units on a scale]	8.2 (1.5)

9. Primary Outcome

Title	Lens Deposits
Description	Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Measure Eyes	223
Mean (Standard Deviation) [Units on a scale]	0.6 (0.7)

10. Primary Outcome

Title	Lens Deposits
Description	Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Measure eyes	224
Mean (Standard Deviation) [Units on a scale]	0.8 (0.7)

11. Primary Outcome

Title	Corrected Visual Acuity
Description	Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Measure Eyes	222
Mean (Standard Deviation) [logMAR]	0.04 (0.07)

12. Primary Outcome

Title	Corrected Visual Acuity
Description	Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Measure Participants	112
Measure Eyes	223
Mean (Standard Deviation) [logMAR]	0.04 (0.08)

Adverse Events

Time Frame	Adverse events were collected for the duration of the trial.
Arm/Group Title	Lotrafilcon B
Arm/Group Description	Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
All Cause Mortality
	Lotrafilcon B
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lotrafilcon B
	Affected / at Risk (%)	# Events
Total	0/117 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B
	Affected / at Risk (%)	# Events
Total	0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.