N/A
Completed N=48
Total30 Sphere Contact Lenses
Contact Lens Complication · Dry Eye Disease
Source: ClinicalTrials.gov NCT05183022 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Visual Analog Scale (VAS) Ocular Comfort — 36.66; 38.06; 33.68; 39.36 units on a scale — p=0.07
Summary
The purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 Sphere CLs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Ocular Comfort |
36.66; 38.06; 33.68; 39.36; 31.26; 33.84 | 0.07 |
Eligibility Criteria
Inclusion Criteria
- Current contact lens wearers who have 20/20 visual acuity or better
- Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
- Astigmatism better than or equal to 0.50 D in each eye
- Must have regularly worn 2 week or monthly contact lenses within the past 6 months
- Must provide a glasses prescription that is is less than 3 years old
- Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day
Exclusion Criteria
- Past or Current hard CL use
- Any known systemic health conditions that are thought to alter tear film physiology
- History of viral eye disease
- History of ocular surgery
- History of severe ocular trauma
- Active ocular infection or inflammation
- Currently using isotretinoin-derivatives
- Currently using ocular medications
- Currently using rewetting drops or artificial tear
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT05183022). 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.