Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01809197
• Collaborator: (none)
• Enrollment: 387
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia; Hyperopia; Astigmatism; Presbyopia	Device: Lotrafilcon B contact lenses; Device: Senofilcon A contact lenses; Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS); Device: Habitual Multi-Purpose Solution (MPS)	N/A

Detailed Description

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 387 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Air Optix/OFPM Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions; Other Names: AIR OPTIX® AQUA AIR OPTIX® AQUA Multifocal AIR OPTIX® for Astigmatism ; Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS); Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions; Other Names: OPTI-FREE® PureMoist™
Active Comparator: Acuvue Oasys/Habitual MPS Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system	Device: Senofilcon A contact lenses; Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions; Other Names: ACUVUE® OASYS® with HYDRACLEAR® PLUS ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS ; Device: Habitual Multi-Purpose Solution (MPS); Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Outcome Measures

Primary Outcome Measures

1. Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses" [Day 30; after 4 hours of lens wear]

   Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sign informed consent.

• Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.

• Willing to wear contact lenses on a daily wear basis for the duration of the study.

• Currently using a multi-purpose solution, as specified in protocol.

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

• Willing to follow the study procedures and visit schedule.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.

• Currently using any Opti-Free brand of multi-purpose solution.

• Must wear contact lenses on an extended wear (overnight) basis during the study.

• Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.

• Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.

• Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.

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

• Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.

• Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.

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

• Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.

• Participation in any clinical study within 30 days of Visit 1.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jessie Lemp, PhD, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01809197
• Other Study ID Numbers: M-12-056
• First Posted: Mar 12, 2013
• Last Update Posted: Jul 22, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Alcon Research: Refractive error; Myopia; Hyperopia; Astigmatism; Presbyopia; Contact lenses; Contact lens solution; Comfort
• Additional relevant MeSH terms: Myopia; Astigmatism; Presbyopia; Refractive Errors; Hyperopia; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 22 study sites located in the US.
Pre-assignment Detail	Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).

Arm/Group Title	Air Optix/OFPM	Acuvue Oasys/Habitual MPS
Arm/Group Description	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Period Title: Overall Study
STARTED	187	185
COMPLETED	177	177
NOT COMPLETED	10	8

Baseline Characteristics

Arm/Group Title	Air Optix/OFPM	Acuvue Oasys/Habitual MPS	Total
Arm/Group Description	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system	Total of all reporting groups
Overall Participants	187	184	371
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.4 (10.12)	35.0 (11.14)	33.7 (10.70)
Sex: Female, Male (Count of Participants)
Female	141 75.4%	142 77.2%	283 76.3%
Male	46 24.6%	42 22.8%	88 23.7%

Outcome Measures

1. Primary Outcome

Title	Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
Description	Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Time Frame	Day 30; after 4 hours of lens wear

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.

Arm/Group Title	Air Optix/OFPM	Acuvue Oasys/Habitual MPS
Arm/Group Description	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Measure Participants	178	177
Least Squares Mean (Standard Deviation) [units on a scale]	4.2 (0.90)	4.4 (0.66)

Adverse Events

Time Frame	Adverse events (AEs) were collected for duration of study (3 months). This analysis group includes all subjects who were randomized and received study regimen (test or control). Note: 1 subject randomized to Acuvue Oasys was not dispensed study lenses.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. AE data were collected at each study visit.
Arm/Group Title	Air Optix/OFPM		Acuvue Oasys/Habitual MPS
Arm/Group Description	Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system		Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
All Cause Mortality
	Air Optix/OFPM		Acuvue Oasys/Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Air Optix/OFPM		Acuvue Oasys/Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/187 (0%)		0/184 (0%)
Other (Not Including Serious) Adverse Events
	Air Optix/OFPM		Acuvue Oasys/Habitual MPS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/187 (0%)		0/184 (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.