Clinical trial NCT04016623: Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Official title: Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Primary purpose: TREATMENT

Brief summary: An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Detailed description: A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

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.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination

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.

Primary outcomes:
measure: Visibility of Toric Mark
timeFrame: 1 hour
measure: Degree of Lens Orientation
timeFrame: Baseline
measure: Degree of Lens Orientation
timeFrame: 15 minutes
measure: Degree of Lens Orientation
timeFrame: 1 hour
measure: Toric Stability
timeFrame: 15 minutes
measure: Toric Stability
timeFrame: 1 hour
measure: Degree of Rotational Recovery
timeFrame: 15 minutes
measure: Degree of Rotational Recovery
timeFrame: 1 hour
measure: Toric Fit Acceptance
timeFrame: 15 minutes
measure: Toric Fit Acceptance
timeFrame: 1 hour
measure: Toric Fit Preference
timeFrame: Baseline
measure: Toric Fit Preference
timeFrame: 1 hour
Secondary outcomes:
measure: Measurement of Lens Horizontal Centration
timeFrame: 15 Minutes
measure: Measurement of Lens Horizontal Centration
timeFrame: 1 hour
measure: Measurement of Lens Vertical Centration
timeFrame: 15 minutes
measure: Measurement of Lens Vertical Centration
timeFrame: 1 hour
measure: Measurement of Lens Movement
timeFrame: 15 minutes
measure: Measurement of Lens Movement
timeFrame: 1 hour
measure: Lens Push-Up
timeFrame: 15 minutes
measure: Lens Push-Up
timeFrame: 1 hour
measure: Primary Lens Gaze Lag
timeFrame: 15 minutes
measure: Primary Lens Gaze Lag
timeFrame: 1 hour
measure: General Lens Fit Acceptance
timeFrame: 15 minutes
measure: General Lens Fit Acceptance
timeFrame: 1 hour
measure: Up Gaze Lag
timeFrame: 15 minutes
measure: Up Gaze Lag
timeFrame: 1 hour
measure: General Lens Fit Preference
timeFrame: Baseline
measure: General Lens Fit Preference
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
affiliation: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
name: Pete S Kollbaum, OD PhD
role: PRINCIPAL_INVESTIGATOR
References: