Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01684033
• Collaborator: (none)
• Enrollment: 207
• 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 Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia; Contact Lens Comfort	Device: Opti-Free® PureMoist® MPDS; Device: Biotrue™ MPS; Device: Habitual contact lenses	N/A

Detailed Description

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution 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: 207 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 1
• 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 - Biotrue Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. 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: Biotrue™ MPS; Other Names: Biotrue™ ; 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: Biotrue - PureMoist Biotrue™ MPS 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: Biotrue™ MPS; Other Names: Biotrue™ ; 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. Corneal Staining [Day 30]

   Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.

2. Change From Baseline in Corneal Staining at Day 30 [Baseline (Day 0), Day 30]

   Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.

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 one 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 two days during the study;

• Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) 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 multipurpose solution such as daily or enzyme cleaners within the one 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: NCT01684033
• Other Study ID Numbers: M-12-038; 1941/ALC
• First Posted: Sep 12, 2012
• Last Update Posted: Apr 17, 2014
• Last Verified: Mar 1, 2014

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

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.
Pre-assignment Detail	Of the 207 enrolled, 9 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) (198).

Arm/Group Title	PureMoist - Biotrue	Biotrue - PureMoist
Arm/Group Description	Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.	Biotrue™ MPS, 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	99	99
COMPLETED	95	98
NOT COMPLETED	4	1
Period Title: Period 1, First 30 Days
STARTED	95	98
COMPLETED	94	98
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	PureMoist / Biotrue
Arm/Group Description	Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
Overall Participants	198
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.7 (11.48)
Sex: Female, Male (Count of Participants)
Female	151 76.3%
Male	47 23.7%

Outcome Measures

1. Primary Outcome

Title	Corneal Staining
Description	Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis population group includes all participants who were exposed to both treatment regimens.

Arm/Group Title	PureMoist	Biotrue
Arm/Group Description	Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.	Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Measure Participants	192	192
Mean (Standard Deviation) [Units on a scale]	1.9 (2.30)	2.8 (2.62)

2. Primary Outcome

Title	Change From Baseline in Corneal Staining at Day 30
Description	Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Time Frame	Baseline (Day 0), Day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PureMoist	Biotrue
Arm/Group Description	Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.	Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
Measure Participants	192	192
Mean (Standard Deviation) [units on a scale]	0.7 (2.59)	1.6 (2.91)

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		Biotrue
Arm/Group Description	Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.		Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
All Cause Mortality
	PureMoist		Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PureMoist		Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/194 (0%)
Other (Not Including Serious) Adverse Events
	PureMoist		Biotrue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/196 (0%)		0/194 (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.