Clinical trial NCT02518490: A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Official title: A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.

The study results were not used for design validation of test lens.

Detailed description: Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.

The study results were not used for design validation of test lens.

Eligibility criteria: Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. Is at least 18 years of age for the USA 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 an adapted soft contact lens wearer;
  5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;
  6. Has no more than 0.75 diopters of refractive astigmatism;
  7. Willing to wear contact lens in both eyes;
  8. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
  9. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

     Exclusion Criteria:
* Subjects will not be eligible to take part in the study if:

  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 pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery; \* 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: Subjective Ratings for Comfort After Lens Insertion
timeFrame: Baseline (5 minutes post lens dispensing)
measure: Subjective Ratings for Comfort After Lens Insertion
timeFrame: 4 weeks
measure: Percentage of Participants With a Lens Preference Based on Subjective Comfort
timeFrame: Baseline (5 minutes post lens dispensing)
measure: Percentage of Participants With a Lens Preference Based on Subjective Comfort
timeFrame: 4 weeks
measure: Lens Wettability
timeFrame: Baseline (5 minutes post lens dispensing)
measure: Lens Wettability
timeFrame: 4 weeks
measure: Lens Surface Deposition
timeFrame: Baseline (5 minutes post lens dispensing)
measure: Lens Surface Deposition
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
Study officials:
affiliation: Clinical Research Center, University of California, Berkeley
name: Meng Lin
role: PRINCIPAL_INVESTIGATOR
References: