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N/A Completed N=69 Randomized Single-blind Treatment

Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Astigmatism
Source: ClinicalTrials.gov NCT01055132 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Monocular Visual Acuity on LogMAR Scale — -0.065; -0.038 logMAR

Summary

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Monocular Visual Acuity on LogMAR Scale		 -0.065; -0.038 —
PRIMARY
Binocular Visual Acuity on LogMAR Scale		 -0.122; -0.108 —
PRIMARY
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire		 56.4; 44.0 —
PRIMARY
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.		 52.7; 44.7 —

Eligibility Criteria

Inclusion Criteria

  • The subject must be between 18 and 40 years old.
  • The subject must have normal eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
  • The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
  • The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
  • The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
  • The subject must be an adapted wearer of soft toric contact lenses in both eyes.
  • The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
  • Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities that 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
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Diabetes
  • Strabismus
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01055132). 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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