Assessment of Lotrafilcon A Contact Lenses

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01185834
• Collaborator: (none)
• Enrollment: 118
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Lotrafilcon A upgrade soft contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Assessment of Lotrafilcon A Contact Lenses
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. Overall Comfort [3 months of wear, replacing lenses monthly]

   As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary Outcome Measures

1. Overall Lens Fit [3 months of wear, replacing lenses monthly]

   As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have normal ocular findings.

• Be able to wear the study lenses in the available powers.

• Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.

• Wear Night & Day contact lenses.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Require concurrent ocular medication.

• Eye injury or surgery within twelve weeks prior to enrollment.

• Currently enrolled in an ophthalmic clinical trial.

• Any active corneal infection.

• Corneal refractive surgery.

• Wear AIR OPTIX NIGHT & DAY AQUA lenses.

• 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: NCT01185834
• Other Study ID Numbers: P-335-C-015
• First Posted: Aug 20, 2010
• Last Update Posted: Jul 10, 2012
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Thirteen US optometry sites recruited and enrolled subjects for this study.

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Period Title: Overall Study
STARTED	118
COMPLETED	104
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Overall Participants	118
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	84 71.2%
Male	34 28.8%

Outcome Measures

1. Primary Outcome

Title	Overall Comfort
Description	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	3 months of wear, replacing lenses monthly

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Measure Participants	103
Mean (Standard Deviation) [units on a scale]	8.4 (1.6)

2. Secondary Outcome

Title	Overall Lens Fit
Description	As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time Frame	3 months of wear, replacing lenses monthly

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
Measure Participants	103
Measure Eyes	206
Mean (Standard Deviation) [units on a scale]	0.0 (0.3)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 143 days.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Lotrafilcon A
Arm/Group Description	Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
All Cause Mortality
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	0/118 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	0/118 (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.