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N/A Completed N=98 Randomized Single-blind Treatment

Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Source: ClinicalTrials.gov NCT01093625 ↗
Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Papillary Conjunctivitis — 0.98; 0.47 units on a scale

Summary

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Papillary Conjunctivitis
0.98; 0.47
PRIMARY
Conjunctival Hyperemia
0.26; 0.28
PRIMARY
Limbal Hyperemia
0.56; 0.30
PRIMARY
Corneal Staining
0.26; 0.12
PRIMARY
Conjunctival Staining
1.41; 0.39
PRIMARY
Corneal Neovascularization
0.30; 0.09
PRIMARY
Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
-4.97; 0.62
SECONDARY
Comfortable Wearing Time
10.25

Eligibility Criteria

Inclusion Criteria

  • Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
  • Willing to comply with the study visit schedule.
  • Ages 15 to 39.
  • Has access to a cellular telephone with text messaging capabilities.
  • Has a current pair of spectacles.
  • 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
  • Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
  • Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
  • Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
  • They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria

  • Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
  • Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
  • Systemic disease, which might interfere with contact lens wear.
  • Medication usage that may be associated with eye dryness.
  • Use of any topical medication such as eye drops or ointment.
  • Pregnant or lactating (by self-report).
  • Aphakia.
  • Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
  • Have participated in any other clinical trial or research in the two weeks prior to starting this study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01093625). 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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