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N/A Completed N=43 Randomized Single-blind Treatment

Comparison of Two Marketed Lenses in a Controlled Environment

Eye Dryness
Source: ClinicalTrials.gov NCT02212301 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Tear Film Kinetics — 5.590; 6.941 Seconds

Summary

This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.

Outcome Measures

OutcomeResultp-value
PRIMARY
Tear Film Kinetics
5.590; 6.941 —
PRIMARY
Time Controlled Visual Acuity
-0.06; -0.07; 0.07; 0.06 —

Eligibility Criteria

Inclusion Criteria

  • The subject must be 18 years of age and less than 51 years of age;
  • The subject must have read and understood the Participant Information Sheet;
  • The subject must have read, signed and dated the Informed Consent;
  • The subject must be a current planned replacement soft contact lens wearer;
  • The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week
  • The subject must have a refractive error within the range of correction of both study contact lenses;
  • The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
  • The subject must demonstrate an acceptable fit with both study contact lenses;
  • The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule;
  • The subject must have normal eyes with the exception of the need for visual correction.

Exclusion Criteria

  • Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
  • Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
  • Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
  • Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
  • Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
  • A history of herpetic keratitis, ocular surgery or irregular cornea(s).
  • Known pregnancy or lactation during the study period.
  • Enrollment of investigator's office staff, relatives, or members of their respective households.
  • Participation in any clinical trial within 30 days of the enrollment visit.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02212301). 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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