CompletedNCT01684033Updated Apr 17, 2014Results posted

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

An interventional study of Opti-Free® PureMoist® MPDS and Biotrue™ MPS in Myopia, Hyperopia and Contact Lens Comfort, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-17.

Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 207
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Myopia
Hyperopia
Contact Lens Comfort

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Keywords

multi-purpose solution
silicone hydrogel
contact lenses
comfort
Opti-Free
Biotrue

In context

Myopia

1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 207 is above the median of 80 across 803 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

Browse Alcon Research studies →All Alcon studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 207 participants (actual)

Study arms

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 · Device: Biotrue™ MPS · Device: Habitual contact lenses
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 · Device: Biotrue™ MPS · Device: Habitual contact lenses

Interventions

DeviceOpti-Free® PureMoist® MPDS
Also known as: OPTI-FREE® PureMoist™
DeviceBiotrue™ MPS
Also known as: Biotrue™
DeviceHabitual 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.

What researchers measure

Primary outcomes

Corneal Staining
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
Change From Baseline in Corneal Staining at 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.
Time frame: Baseline (Day 0), Day 30

Results

Posted Apr 17, 2014

Participant flow

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.

Period 1, First 30 Days

Participant flow — Period 1, First 30 Days
Milestone	PureMoist - Biotrue	Biotrue - PureMoist
Started	99	99
Completed	95	98
Not completed	4	1
Withdrew: Adverse event	1	1
Withdrew: Noncompliance	1	0
Withdrew: Withdrawal by subject	1	0
Withdrew: Lost to follow-up	1	0

Period 2, Second 30 Days

Participant flow — Period 2, Second 30 Days
Milestone	PureMoist - Biotrue	Biotrue - PureMoist
Started	95	98
Completed	94	98
Not completed	1	0
Withdrew: Adverse event	1	0

Outcome measures

PrimaryCorneal Staining

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
Reported as:: Mean · Units on a scale

Corneal Staining
Units on a scale	PureMoist	Biotrue
Corneal Staining	1.9 ± 2.30	2.8 ± 2.62

PrimaryChange From Baseline in Corneal Staining at Day 30

Time frame:: Baseline (Day 0), Day 30
Reported as:: Mean · units on a scale

Change From Baseline in Corneal Staining at Day 30
units on a scale	PureMoist	Biotrue
Change From Baseline in Corneal Staining at Day 30	0.7 ± 2.59	1.6 ± 2.91

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PureMoist	—	0/196 (0%)	0/196 (0%)
Biotrue	—	0/194 (0%)	0/194 (0%)

Baseline characteristics

This analysis population includes all participants who were exposed to a study regimen (test or control).

Age, Continuous
Age, Continuous(years)	PureMoist / Biotrue
Mean	31.7 ± 11.48

Sex: Female, Male
Sex: Female, Male(Participants)	PureMoist / Biotrue
Female	151
Male	47

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01684033
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Sep 12, 2012
Start date: Nov 2012
Primary completion: Mar 2013
Completion: Mar 2013
Results posted: Apr 17, 2014
Last update: Apr 17, 2014

Study contacts

Jessie Lemp, MS

study director · Alcon Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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