N/A
Completed N=10
Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Astigmatism
Source: ClinicalTrials.gov NCT04016623 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Visibility of Toric Mark — 100; 100; 0; 0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visibility of Toric Mark |
100; 100; 0; 0 | — |
| PRIMARY Degree of Lens Orientation |
-1; -1 | — |
| PRIMARY Toric Stability |
5; 4 | — |
| PRIMARY Degree of Rotational Recovery |
16; 12; 9; 10 | — |
| PRIMARY Toric Fit Acceptance |
3.5; 3.4 | — |
| PRIMARY Toric Fit Preference |
33; 57; 10 | — |
| SECONDARY Measurement of Lens Horizontal Centration |
-0.06; -0.08 | — |
| SECONDARY Measurement of Lens Vertical Centration |
0.32; 0.27 | — |
| SECONDARY Measurement of Lens Movement |
0.25; 0.24 | — |
| SECONDARY Lens Push-Up |
47; 47 | — |
| SECONDARY Primary Lens Gaze Lag |
0.20; 0.19 | — |
| SECONDARY General Lens Fit Acceptance |
3.4; 3.4 | — |
| SECONDARY Up Gaze Lag |
0.22; 0.22 | — |
| SECONDARY General Lens Fit Preference |
3; 94; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04016623). 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. Informational only — not medical advice.