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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684046
• Other study ID #: M-12-041
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: March 27, 2014
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.

Description:

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 1 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 2 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), 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 multi-purpose solution such as daily or enzyme cleaners within the 1 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Comfort
• Hyperopia
• Myopia

Intervention

Device:
• Opti-Free® PureMoist® MPDS

• RevitaLens MPDS

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Lens Wear Comfort	Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.	Day 30	No