N/A
N=48
Total30 Sphere Contact Lenses
Contact Lens Complication · Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT05183022 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Visual Analog Scale (VAS) Ocular Comfort — 36.66; 38.06; 33.68; 39.36 units on a scale — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total30 Sphere Contact Lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2022
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 |
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.
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.