Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00933166
• Collaborator: (none)
• Enrollment: 169
• Arm: 1
• Duration (Months): 5

Study Details

Study Description

Brief Summary

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 169 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lotrafilcon A Investigational contact lens worn in both eyes for three months	Device: Lotrafilcon A contact lens; Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Outcome Measures

Primary Outcome Measures

1. Comfort After Insertion [3 months]

   Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.

• Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.

• 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.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in an ophthalmic clinical trial.

• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.

• History of corneal refractive surgery.

• Other protocol-defined inclusion/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: NCT00933166
• Other Study ID Numbers: P-335-C-014v2
• First Posted: Jul 7, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Investigational contact lens worn in both eyes for three months
Period Title: Overall Study
STARTED	169
COMPLETED	151
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Investigational contact lens worn in both eyes for three months
Overall Participants	169
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.3 (12.1)
Sex: Female, Male (Count of Participants)
Female	115 68%
Male	54 32%

Outcome Measures

1. Primary Outcome

Title	Comfort After Insertion
Description	Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.

Arm/Group Title	Lotrafilcon A
Arm/Group Description	Investigational contact lens worn in both eyes for three months
Measure Participants	122
Mean (Standard Deviation) [Units on a Scale]	9.0 (1.6)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 4 months, 16 days.
Arm/Group Title	Lotrafilcon A
Arm/Group Description	Investigational contact lens worn in both eyes for three months
All Cause Mortality
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	0/169 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon A
	Affected / at Risk (%)	# Events
Total	0/169 (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.