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OpenTrials
Completed

NCT Number: NCT01267656

Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Use a lens care system on a regular basis.
  • Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
  • Willing to use drops 4 times per day.

Exclusion criteria

  • Participating in a conflicting study.
  • An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
  • Any scar or neovascularization within the central 4mm of the cornea.
  • Any grade 2 or greater finding during the slit lamp examination
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Aphakic.
  • Amblyopic.
  • Allergic to any component in the study care products.
  • Have had any corneal surgery.

Treatment and study plan

Lubricating and Rewetting Drops

Device

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

AMO Blink Contacts Lubricant Eye Drops

Device

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Primary outcomes

  1. Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.

    Time frame: At 1 week follow up

    Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 28, 2010
Registry last updated
Sep 30, 2020

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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