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OpenTrials
Completed

NCT Number: NCT00799422

Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
  • Read, sign, and date informed consent/HIPAA document;
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
  • Willing and able to discontinue contact lens wear when requested during the study;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Evidence or history of ocular disease or pathology;
  • One functional eye or a monofit lens;
  • Use of concomitant topical ocular prescription or over-the-counter ocular medications;
  • History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Complete Easy Rub

Device

Commercially marketed contact lens solution for contact lens care

Other names: Complete® Easy Rub®

ReNu MultiPlus

Device

Commercially marketed contact lens solution for contact lens care

Other names: ReNu MultiPlus®

CLEAR CARE

Device

Commercially marketed contact lens solution for contact lens care

Other names: Clear Care®

Contact Lenses

Device

Acuvue Oasys silicone hydrogel contact lenses per participant's habitual prescription worn 8-10 hours per day for one week.

Other names: ACUVUE® OASYS®

Primary outcomes

  1. Mean Circumlimbal Conjunctival Staining Score

    Time frame: 1 week

    Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.

Secondary outcomes

  1. Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week

    Time frame: Dispense (Day 0), 1 week

    Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.

  2. Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week

    Time frame: Dispense (Day 0), 1 week

    Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 27, 2008
Registry last updated
Nov 16, 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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