Clinical Evaluation of a Silicone Hydrogel Lens

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01016132
• Collaborator: (none)
• Enrollment: 152
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Outcome Measures

Primary Outcome Measures

1. Overall Preference [4 weeks of wear]

   Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.

• Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.

• Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.

• Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within 12 months prior to enrollment.

• Currently enrolled in any clinical trial.

• History of corneal refractive surgery.

• Other protocol 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: NCT01016132
• Other Study ID Numbers: P-019-C-055
• First Posted: Nov 18, 2009
• Last Update Posted: Jun 29, 2012
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Period Title: Overall Study
STARTED	152
COMPLETED	151
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Overall Participants	152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.5 (10.9)
Sex: Female, Male (Count of Participants)
Female	97 63.8%
Male	55 36.2%

Outcome Measures

1. Primary Outcome

Title	Overall Preference
Description	Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
Time Frame	4 weeks of wear

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	All Participants
Arm/Group Description	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
Measure Participants	145
Strongly Prefer Study Lenses	28 18.4%
Somewhat Prefer Study Lenses	31 20.4%
NO Preference	46 30.3%
Somewhat Prefer "Habitual" Lenses	20 13.2%
Strongly Prefer "Habitual" Lenses	20 13.2%

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 49 days
Adverse Event Reporting Description	Individual exposure: four weeks
Arm/Group Title	All Participants
Arm/Group Description	In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/152 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/152 (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.