CIAN: In-vivo Wettability Grading and Assessment Study

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01010555
• Collaborator: University of Waterloo (Other)
• Enrollment: 25
• Location: 1
• Arms: 4
• Duration (Months): 6
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: lotrafilcon B; Device: balafilcon A; Device: senofilcon A; Device: enfilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lotrafilcon B Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.	Device: lotrafilcon B; Commercially marketed, silicone hydrogel, spherical contact lens; Other Names: Air Optix
Active Comparator: balafilcon A Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.	Device: balafilcon A; Commercially marketed, silicone hydrogel, spherical contact lens; Other Names: PureVision
Active Comparator: senofilcon A Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.	Device: senofilcon A; Commercially marketed, silicone hydrogel, spherical contact lens; Other Names: Acuvue OASYS
Active Comparator: enfilcon A Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.	Device: enfilcon A; Commercially marketed, silicone hydrogel, spherical contact lens; Other Names: Avaira

Outcome Measures

Primary Outcome Measures

1. On-eye Wettability [4 weeks of wear]

   On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• is at least 17 years of age

• has read and signed an information consent letter

• is a current daily wear contact lens wearer

• has acceptable fit with the study lenses

• has had an ocular exam in the last two years

• other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• has any ocular disease

• has undergone corneal refractive surgery or is aphakic

• has any systemic disease affecting ocular health

• is pregnant or lactating

• other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Contact Lens Research: University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• CIBA VISION
• University of Waterloo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01010555
• Other Study ID Numbers: P-368-C-104
• First Posted: Nov 10, 2009
• Last Update Posted: Jul 10, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Four participants were enrolled but not dispensed due to failing inclusion/exclusion criteria (2) and withdrawing consent (2). These participants are included in the Actual Enrollment and Baseline Characteristics calculations, but not Participant Flow.
Pre-assignment Detail	This reporting group includes all enrolled and dispensed participants.

Arm/Group Title	Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A	Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A
Arm/Group Description	Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.	Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
Period Title: First Four Weeks of Wear
STARTED	11	10
COMPLETED	11	10
NOT COMPLETED	0	0
Period Title: First Four Weeks of Wear
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	This reporting group includes all enrolled subjects.
Overall Participants	25
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	20.0
Sex: Female, Male (Count of Participants)
Female	22 88%
Male	3 12%

Outcome Measures

1. Primary Outcome

Title	On-eye Wettability
Description	On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.
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	Lotrafilcon B	Balafilcon A	Senofilcon A	Enfilcon A
Arm/Group Description	Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.	Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
Measure Participants	19	19	19	19
Mean (Standard Deviation) [units on a scale]	1.33 (1.01)	2.11 (1.16)	1.70 (1.09)	2.07 (1.00)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the trial: 166 days.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants.
Arm/Group Title	Lotrafilcon B		Balafilcon A		Senofilcon A		Enfilcon A
Arm/Group Description	Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.		Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.		Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.		Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
All Cause Mortality
	Lotrafilcon B		Balafilcon A		Senofilcon A		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Balafilcon A		Senofilcon A		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)		0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Balafilcon A		Senofilcon A		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)		0/23 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No distribution of trial-specific information without express written permission of Director of Centre for Contact Lens Research.