Clinical trial NCT03499067: A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens
Official title: A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-04-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
Primary purpose: TREATMENT

Brief summary: Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Detailed description: Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.

Eligibility criteria: Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
* Has no more than 0.75 diopters of refractive astigmatism.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
* Known allergy to a product used in this study (ex. Shellfish allergy)
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Primary outcomes:
measure: Lens Surface Wettability
timeFrame: Baseline
measure: Lens Surface Wettability
timeFrame: 2-weeks
measure: Lens Surface Wettability
timeFrame: 4-weeks
measure: Lens Surface Deposits
timeFrame: Baseline
measure: Lens Surface Deposits
timeFrame: 2-weeks
measure: Lens Surface Deposits
timeFrame: 4-weeks
measure: Overall Lens Fit Acceptance
timeFrame: Baseline
measure: Overall Lens Fit Acceptance
timeFrame: 2-Weeks
measure: Overall Lens Fit Acceptance
timeFrame: 4-Weeks
measure: Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
timeFrame: Baseline
measure: Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
timeFrame: 2-weeks
measure: Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
timeFrame: 4-weeks
Secondary outcomes:
measure: Bulbar Conjunctiva Hyperaemia
timeFrame: Baseline
measure: Bulbar Conjunctiva Hyperaemia
timeFrame: 2-weeks
measure: Bulbar Conjunctiva Hyperaemia
timeFrame: 4-weeks
measure: Limbal Conjunctiva Hyperaemia
timeFrame: Baseline
measure: Limbal Conjunctiva Hyperaemia
timeFrame: 2-weeks
measure: Limbal Conjunctiva Hyperaemia
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
References: