N/A
Completed N=64
A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Source: ClinicalTrials.gov NCT04585646 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Subjective Response for Vision Satisfaction — 24; 28; 30; 24 Participants
Summary
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Response for Vision Satisfaction |
24; 28; 30; 24; 4; 7 | — |
| PRIMARY Subjective Response for Overall Vision Satisfaction |
42; 34; 41; 48; 8; 10 | — |
| PRIMARY Subjective Response for Overall Vision Quality |
87; 88 | — |
| SECONDARY Subjective Overall Comfort Satisfaction |
22; 17; 25; 19; 6; 14 | — |
| SECONDARY Subjective Preference for Comfort |
13; 21; 10; 7; 8 | — |
| SECONDARY Lens Surface Wettability Performance |
3.31; 3.40 | — |
| SECONDARY Horizontal Lens Centration |
-0.13; -0.17 | — |
| SECONDARY Vertical Lens Centration |
0.09; 0.12 | — |
| SECONDARY Post-blink Movement |
0.29; 0.32 | — |
| SECONDARY Lens Horizontal Mobility Rating |
2.36; 2.41 | — |
| SECONDARY Corneal Staining Extent |
0.00; 0.00; 0.02; 0.01; 0.00; 0.00 | — |
| SECONDARY Overall Lens Fit Acceptance |
3.22; 3.11 | — |
| SECONDARY Lens Handling Satisfaction |
27; 14; 20; 27; 8; 11 | — |
| SECONDARY Subjective Overall Lens Handling |
87; 83 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years of age and has full legal capacity to volunteer.
- Is no greater than 55 years of age.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
- Has spectacle cylinder ≤1.00D in both eyes.
- Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
- Wears CLs in both eyes (monovision acceptable, but not monofit)
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
- Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
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 strabismus/amblyopia.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating or planning a pregnancy.
- Is participating in any concurrent clinical or research study.
Data sourced from ClinicalTrials.gov (NCT04585646). 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.