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N/A Completed N=180 Randomized Double-blind Treatment

Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

Source: ClinicalTrials.gov NCT01094730 ↗
Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Lens Front Surface Deposits at Day 7 — 1.53; 1.53 dichotomized grading scale

Summary

The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Lens Front Surface Deposits at Day 7
1.53; 1.53 —
PRIMARY
Lens Front Surface Deposits at Day 14
1.61; 1.67 —
SECONDARY
Subject Reported Overall Lens Comfort at Day 7
60.7787; 59.3206 —
SECONDARY
Subject Reported Overall Lens Comfort at Day 14
57.3230; 55.4675 —

Eligibility Criteria

Inclusion Criteria

  • The subject must be at least 18 years of age and no more than 39 years of age.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  • 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 (NCT01094730). 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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