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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01684033
First received: September 10, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention
Myopia
Hyperopia
Contact Lens Comfort
Device: Opti-Free® PureMoist® MPDS
Device: Biotrue™ MPS
Device: Habitual contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Corneal Staining at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ] [ Designated as safety issue: No ]
    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.


Enrollment: 207
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: OPTI-FREE® PureMoist™
Device: Biotrue™ MPS
Other Name: 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.
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 Name: OPTI-FREE® PureMoist™
Device: Biotrue™ MPS
Other Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684033

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jessie Lemp, MS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01684033     History of Changes
Other Study ID Numbers: M-12-038, 1941/ALC
Study First Received: September 10, 2012
Results First Received: March 12, 2014
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
Germany: Ethics Commission

Keywords provided by Alcon Research:
multi-purpose solution
silicone hydrogel
contact lenses
comfort
Opti-Free
Biotrue

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014