Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01684046
First received: September 10, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to compare clinical and comfort outcomes of two marketed multi-purpose contact lens solutions.


Condition Intervention
Myopia
Contact Lens Comfort
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution
Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective lens wear comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 196
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
Opti-Free, then RevitaLens
Opti-Free PureMoist Multi-Purpose Disinfecting solution used first, followed by RevitaLens OcuTec Multi-Purpose Disinfecting Solution. Each product used 30 days for contact lens care as specified in protocol, with a 2-day washout prior to each 30-day period.
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: OPTI-FREE® PureMoist™
Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: RevitaLens OcuTec®
RevitaLens, then Opti-Free
RevitaLens Ocutec Multi-Purpose Disinfecting Solution, followed by Opti-Free PureMoist Multi-Purpose Disinfecting Solution. Each product used 30 days for contact lens care as specified in protocol, with a 2-day washout prior to each 30-day period.
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: OPTI-FREE® PureMoist™
Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: RevitaLens OcuTec®

  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 RevitaLens) 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), Alexidine 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: NCT01684046

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, United States, 76134
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: NCT01684046     History of Changes
Other Study ID Numbers: M-12-041
Study First Received: September 10, 2012
Last Updated: March 19, 2013
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
RevitaLens

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014