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Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Not Applicable
Completed
Conditions
Dry Eye
Interventions
Device: Lubricating and Rewetting Drops
Device: AMO Blink Contacts Lubricant Eye Drops
Registration Number
NCT01267656
Lead Sponsor
Bausch & Lomb Incorporated
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
168
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Lubricating and Rewetting DropsLubricating and Rewetting DropsLubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.
AMO Blink Contacts Lubricant Eye DropsAMO Blink Contacts Lubricant Eye DropsAMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week
Primary Outcome Measures
NameTimeMethod
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Bausch & Lomb

🇺🇸

Rochester, New York, United States

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