Clinical trial NCT02588573: Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Official title: Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 103
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Detailed description: This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Eligibility criteria: Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
  5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);
  6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
  7. Demonstrates an acceptable fit with the study lenses;
  8. Is usually able to wear contact lenses for at least 8 hours per day.

Exclusion Criteria:

* A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active\* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
  6. Is aphakic;
  7. Has undergone refractive error surgery.
  8. Has participated in the previous somfofilcon A study (ORE# 20893)

     * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Primary outcomes:
measure: Comfort
timeFrame: 8 hours
measure: Comfort Preference
timeFrame: Baseline and 8 hours
measure: Bulbar Hyperemia
timeFrame: Baseline and 8 hours
measure: Limbal Hyperemia
timeFrame: Baseline and 8 hours
measure: Conjunctival Staining
timeFrame: 8 hours
measure: Visual Acuity
timeFrame: Baseline and 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
city: Waterloo
country: Canada
facility: University of Waterloo
Study officials:
affiliation: Centre for Contact Lens Research
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: