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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014