Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01240135
• Collaborator: (none)
• Enrollment: 89
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Fit; Myopia	Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Galyfilcon A contact lenses (Acuvue Advance)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: FID 114576A / renu fresh FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.	Device: FID 114675A multi-purpose disinfecting solution (MPDS); Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.; Other Names: Alcon Multi-Purpose Disinfecting Solution (MPDS) ; Device: renu fresh Multi-Purpose Solution (MPS); Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.; Other Names: Bausch + Lomb renu® fresh™ Multi-Purpose Solution ; Device: Galyfilcon A contact lenses (Acuvue Advance); A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.; Other Names: Acuvue® Advance®
Other: renu fresh / FID 114675A Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.	Device: FID 114675A multi-purpose disinfecting solution (MPDS); Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.; Other Names: Alcon Multi-Purpose Disinfecting Solution (MPDS) ; Device: renu fresh Multi-Purpose Solution (MPS); Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.; Other Names: Bausch + Lomb renu® fresh™ Multi-Purpose Solution ; Device: Galyfilcon A contact lenses (Acuvue Advance); A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.; Other Names: Acuvue® Advance®

Outcome Measures

Primary Outcome Measures

1. Lens Fit [Day 14 of lens wear]

   As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.

Secondary Outcome Measures

1. Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score [Day 14 of lens wear]

   The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older.

• History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.

• Wear contact lenses a minimum of 8 hours per day prior to Visit 1.

• Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.

• Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.

• History of intolerance or known sensitivity to any component of the treatments.

• Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01240135
• Other Study ID Numbers: C-10-030
• First Posted: Nov 15, 2010
• Last Update Posted: Jul 12, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Alcon Research: Contact Lens Wear; Contact Lens Solution; Multi-purpose disinfecting solution; Myopia
• Additional relevant MeSH terms: Myopia; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 US study centers.

Arm/Group Title	FID 114576A / Renu Fresh	Renu Fresh / FID 114675A
Arm/Group Description	FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.	Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
Period Title: Period One, 14 Days of Wear
STARTED	44	45
COMPLETED	44	45
NOT COMPLETED	0	0
Period Title: Period One, 14 Days of Wear
STARTED	44	45
COMPLETED	43	43
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	FID 114576A / Renu Fresh	Renu Fresh / FID 114675A	Total
Arm/Group Description	FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.	Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.	Total of all reporting groups
Overall Participants	44	45	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.3 (11.44)	31.4 (9.71)	32.8 (10.64)
Sex: Female, Male (Count of Participants)
Female	31 70.5%	30 66.7%	61 68.5%
Male	13 29.5%	15 33.3%	28 31.5%

Outcome Measures

1. Primary Outcome

Title	Lens Fit
Description	As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
Time Frame	Day 14 of lens wear

Outcome Measure Data

Analysis Population Description

Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.

Arm/Group Title	FID 114576A	Renu Fresh
Arm/Group Description	FID 114675A used for contact lens care per protocol-specified instructions for 14 days.	Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
Measure Participants	87	88
Number [percentage of acceptable fit]	100	100

2. Secondary Outcome

Title	Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
Description	The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.
Time Frame	Day 14 of lens wear

Outcome Measure Data

Analysis Population Description

Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.

Arm/Group Title	FID 114576A	Renu Fresh
Arm/Group Description	FID 114675A used for contact lens care per protocol-specified instructions for 14 days.	Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
Measure Participants	87	88
Mean (Standard Deviation) [units on a scale]	0.6 (2.49)	1.4 (2.63)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 11 October 2010 through 2 February 2011.
Adverse Event Reporting Description	All subjects who used study treatment or potentially used study treatment were evaluated for safety analysis.
Arm/Group Title	FID 114576A		Renu Fresh
Arm/Group Description	FID 114675A used for contact lens care per protocol-specified instructions for 14 days.		Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
All Cause Mortality
	FID 114576A		Renu Fresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	FID 114576A		Renu Fresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	FID 114576A		Renu Fresh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/89 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Alcon reserves the right of prior review of any publication or presentation of information related to the study.