Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Myopia Clinical Trial

Official title:

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809197
• Other study ID #: M-12-056
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: June 25, 2014
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.

Description:

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign informed consent.

• Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.

• Willing to wear contact lenses on a daily wear basis for the duration of the study.

• Currently using a multi-purpose solution, as specified in protocol.

• Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.

• Willing to follow the study procedures and visit schedule.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.

• Currently using any Opti-Free brand of multi-purpose solution.

• Must wear contact lenses on an extended wear (overnight) basis during the study.

• Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.

• Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.

• Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.

• Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.

• Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.

• Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.

• Ocular surgery within the 12 months prior to Visit 1.

• Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.

• Participation in any clinical study within 30 days of Visit 1.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia
• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
• Senofilcon A contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
• OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
• Habitual Multi-Purpose Solution (MPS)
Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"	Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.	Day 30; after 4 hours of lens wear	No