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Phase 4 N=50 Randomized Single-blind Treatment

Corneal and Conjunctival Sensitivity and Staining Study

Myopia · Hyperopia

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Corneal Sensitivity — 26.9; 25.5 percent CO2

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Optifree RepleniSH Multipurpose Disinfecting Solution (Drug); ReNu Multiplus Multipurpose Solution (Drug)
Age
Pediatric, Adult · 17+ yrs
Sex
All
Sponsor
University of Waterloo
Primary completion
Dec 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Corneal Sensitivity
25.5; 22.1
PRIMARY
Corneal Sensitivity
25.5; 22.1
PRIMARY
Conjunctival Sensitivity
50.5; 46.2
PRIMARY
Conjunctival Sensitivity
50.5; 46.2
SECONDARY
Corneal Staining Grade
4.7; 49.9
SECONDARY
Corneal Staining Grade
4.7; 49.9

Summary

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

Eligibility Criteria

Inclusion Criteria

An eligible participant is one who:

  • Is between 17-45 years old and has full legal capacity to volunteer.
  • Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
  • Has normal binocular vision (no strabismus, no amblyopia).
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
  • Has astigmatism less than or equal to -1.00DC.
  • Agrees to wear the study lenses on a daily wear basis.
  • Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria

A person is ineligible if he/she:

  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other clinical or research study.
  • Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
  • Has ocular or systemic allergies that could adversely affect contact lens wear.
  • Currently wears lenses on a continuous or extended wear basis.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
  • Is a rigid lens wearer.
  • Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00455455). 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.

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