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N/A Completed N=100 Randomized Single-blind Screening

A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Source: ClinicalTrials.gov NCT01412983 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Visual Acuity — -0.054; -0.051 LogMAR

Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity
-0.054; -0.051 —
SECONDARY
Overall Comfort
81.9; 82.7 —

Eligibility Criteria

Inclusion Criteria

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
  • Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  • Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.

Exclusion Criteria

  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
  • Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any scar or neovascularization within the central 4mm of the cornea.
  • Have had any corneal surgery.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Currently wear monovision, multifocal, or toric contact lenses.
  • Allergic to any component in the study care products.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01412983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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