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OpenTrials
Completed

NCT Number: NCT00961051

Evaluation of an Investigational Multi-Purpose Solution (MPS)

The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

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Key information

Conditions

Study Focus is Healthy Contact Lens Wearers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Complete Family Vision Center, San Diego, California, United States

Loading trial locations.

About this study

A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have successfully worn hydrogel contact lenses of the same material to be worn during the study
  • Have normal eyes (with the exception of unaided visual acuity)
  • Have successfully used a multi-purpose contact lens care solution
  • Have acceptable visual acuity and lens wearing comfort at time of enrollment

Exclusion criteria

  • Concurrently enrolled another clinical trial
  • Have a known sensitivity to any study product ingredient(s)
  • Have a condition that may put them at significant risk

Treatment and study plan

Investigational MPS

Device

Multi-purpose solution

Other names: Cobra

OPTI-FREE

Device

Multi-purpose solution

Other names: RepleniSH

Primary outcomes

  1. Mean Lens Cleanliness as Measured by Light Reflectance

    Time frame: Day 30

    Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).

Secondary outcomes

  1. Number of Subjects With no Corneal Staining

    Time frame: Day 180

    Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

Evaluation of an Investigational MPS

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 18, 2009
Registry last updated
Jan 7, 2014

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.