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Completed

NCT Number: NCT01240135

Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

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Key information

Conditions

Contact Lens Fit Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older.
  • History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
  • Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
  • Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
  • History of intolerance or known sensitivity to any component of the treatments.
  • Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FID 114675A multi-purpose disinfecting solution (MPDS)

Device

Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.

Other names: Alcon Multi-Purpose Disinfecting Solution (MPDS)

renu fresh Multi-Purpose Solution (MPS)

Device

Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.

Other names: Bausch + Lomb renu® fresh™ Multi-Purpose Solution

Galyfilcon A contact lenses (Acuvue Advance)

Device

A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.

Other names: Acuvue® Advance®

Primary outcomes

  1. Lens Fit

    Time frame: Day 14 of lens wear

    As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.

Secondary outcomes

  1. Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score

    Time frame: Day 14 of lens wear

    The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2010
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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