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N/A Completed N=216 Randomized Single-blind Treatment

A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses

Source: ClinicalTrials.gov NCT01583868 ↗
Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Visual Acuity — -0.089; -0.087; -0.086; -0.086 logMAR

Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Acuity
-0.089; -0.087; -0.086; -0.086
SECONDARY
Symptoms and Complaints
91.3; 91.3; 83.1; 92.6; 89.6; 88.2

Eligibility Criteria

Inclusion Criteria

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • 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 diopters (D) to -6.00 D in each eye.
  • Must agree to wear the study lenses on a daily wear basis for the duration of the study.
  • Must be willing to use a lens care system on a regular basis.
  • If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.

Exclusion Criteria

  • Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
  • Have 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 scar or neovascularization within the central 4mm of the cornea.
  • Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Anisometropia (spherical equivalent) of greater than 2.00 D.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Aphakic.
  • Amblyopic.
  • Allergic to any component in the study products.
  • Have had any corneal surgery (ie, refractive surgery).
  • Currently wear monovision correction, multifocal, or toric contact lenses.
  • Ocular astigmatism greater than 1.00 D in either eye.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01583868). 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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