Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01684046
• Collaborator: (none)
• Enrollment: 196
• Arms: 2
• Duration (Months): 3.9

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Contact Lens Comfort	Device: Opti-Free® PureMoist® MPDS; Device: RevitaLens MPDS; Device: Habitual Contact Lenses	N/A

Detailed Description

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

Study Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: PureMoist - RevitaLens Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.	Device: Opti-Free® PureMoist® MPDS; Other Names: OPTI-FREE® PureMoist® ; Device: RevitaLens MPDS; Other Names: RevitaLens OcuTec® COMPLETE® RevitaLens ; Device: Habitual Contact Lenses; Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
Other: RevitaLens - PureMoist RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.	Device: Opti-Free® PureMoist® MPDS; Other Names: OPTI-FREE® PureMoist® ; Device: RevitaLens MPDS; Other Names: RevitaLens OcuTec® COMPLETE® RevitaLens ; Device: Habitual Contact Lenses; Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.

Outcome Measures

Primary Outcome Measures

1. Subjective Lens Wear Comfort [Day 30]

   Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to Visit 1;

• Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study;

• Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1;

• Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;

• Have access, capability and willingness to review and answer text messages;

• Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;

• Willing to follow the study procedures and visit schedule;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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

• Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;

• Monocular (only one eye with functional vision) or fit with only one lens;

• Wearing toric or multifocal contact lenses or fit with monovision;

• Use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to Visit 1;

• Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;

• Abnormal ocular condition observed during the Visit 1 slit-lamp examination;

• Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;

• Ocular surgery within the 12 months prior to Visit 1;

• Participation in any other clinical trial within 30 days of enrollment;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jessie Lemp, MS, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01684046
• Other Study ID Numbers: M-12-041
• First Posted: Sep 12, 2012
• Last Update Posted: Apr 29, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Alcon Research: multi-purpose solution; silicone hydrogel; contact lenses; comfort; Opti-Free; RevitaLens
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 5 study centers located in the US, 2 study centers located in the UK, and 3 study centers located in Germany.
Pre-assignment Detail	Of the 196 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (192).

Arm/Group Title	PureMoist - RevitaLens	RevitaLens - PureMoist
Arm/Group Description	Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.	RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Period Title: Period 1, First 30 Days
STARTED	97	95
COMPLETED	97	93
NOT COMPLETED	0	2
Period Title: Period 1, First 30 Days
STARTED	97	93
COMPLETED	97	93
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PureMoist / RevitaLens
Arm/Group Description	Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
Overall Participants	192
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.0 (11.42)
Sex: Female, Male (Count of Participants)
Female	142 74%
Male	50 26%

Outcome Measures

1. Primary Outcome

Title	Subjective Lens Wear Comfort
Description	Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.

Arm/Group Title	PureMoist	RevitaLens
Arm/Group Description	Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.	RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Measure Participants	183	183
Mean (Standard Deviation) [units on a scale]	4.3 (0.89)	4.3 (0.72)

Adverse Events

Time Frame	Adverse events (AE) were collected for the duration of the study (4 months). AEs were elicited by non-direct questioning of the participant and spontaneous reporting by the participant. AEs were recorded at every visit.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. This analysis population includes all participants who were exposed to a study regimen (test or control), based on treatment-specific exposure.
Arm/Group Title	PureMoist		RevitaLens
Arm/Group Description	Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.		RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
All Cause Mortality
	PureMoist		RevitaLens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PureMoist		RevitaLens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/192 (0%)
Other (Not Including Serious) Adverse Events
	PureMoist		RevitaLens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/192 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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