Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01007916
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon B / Habitual Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.; Device: Habitual contact lens; Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Other: Habitual / Lotrafilcon B Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Device: Lotrafilcon B contact lens; Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.; Device: Habitual contact lens; Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Outcome Measures

Primary Outcome Measures

1. Comfort Upon Insertion [4 weeks of wear]

   Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.

• Wears lenses at least 5 days per week and at least 12 hours per day.

• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.

• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".

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

• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

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

Exclusion Criteria:

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

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

• Currently enrolled in any clinical trial.

• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.

• Currently sleeping in contact lenses for more than 6 consecutive nights.

• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.

• 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: NCT01007916
• Other Study ID Numbers: P-336-C-016
• First Posted: Nov 5, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Arm/Group Title	Lotrafilcon B / Habitual	Habitual / Lotrafilcon B
Arm/Group Description	Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.	Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Period Title: Period 1, 4 Weeks of Wear
STARTED	23	26
COMPLETED	22	26
NOT COMPLETED	1	0
Period Title: Period 1, 4 Weeks of Wear
STARTED	22	25
COMPLETED	21	25
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	This reporting group includes all enrolled and dispensed subjects
Overall Participants	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.4 (10.2)
Sex: Female, Male (Count of Participants)
Female	34 69.4%
Male	15 30.6%

Outcome Measures

1. Primary Outcome

Title	Comfort Upon Insertion
Description	Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Time Frame	4 weeks of wear

Outcome Measure Data

Analysis Population Description

Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.

Arm/Group Title	Lotrafilcon B	Habitual
Arm/Group Description	Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.	Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Measure Participants	47	46
Mean (Standard Deviation) [Units on a Scale]	8.7 (2.0)	9.2 (0.9)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 86 days.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Lotrafilcon B		Habitual
Arm/Group Description	Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.		Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
All Cause Mortality
	Lotrafilcon B		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Habitual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/48 (0%)

Limitations/Caveats

Participants were masked to lotrafilcon B lenses only.

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.