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N/A Completed N=38 Randomized Other

Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

Source: ClinicalTrials.gov NCT01192542 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Monocular Visual Acuity Assessment — -0.05; -0.04 logMAR

Summary

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Outcome Measures

OutcomeResultp-value
PRIMARY
Monocular Visual Acuity Assessment
-0.05; -0.04 —
PRIMARY
Binocular Visual Acuity
-0.08; -0.08 —
SECONDARY
Limbal Redness of Grade 3 or Above
0; 0 —
SECONDARY
Bulbar Redness of Grade 3 or Above
0; 0 —

Eligibility Criteria

Inclusion Criteria

  • The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
  • Any cylinder power must be ≤ -0.75D.
  • The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01192542). 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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