N/A
Completed N=32
Clinical Evaluation of Daily Disposable Contact Lenses
Source: ClinicalTrials.gov NCT02097030 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Overall Lens Preference - All Study Lenses — 5; 3; 8; 4 participants
Summary
The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Lens Preference - All Study Lenses |
5; 3; 8; 4; 3; 7 | — |
| PRIMARY Overall Lens Preference - Hydrogel vs. Filcon II 3 |
8; 8; 7; 7 | — |
| SECONDARY Subjective Response for Comfort |
90.3; 94.1; 93.2; 84.5; 82.0; 81.5 | — |
| SECONDARY Subjective Response for Vision |
93.8; 93.0; 94.1; 94.8; 90.6; 95.2 | — |
| SECONDARY Subjective Response for Insertion |
94.6; 86.4; 91.0 | — |
| SECONDARY Subjective Response for Handling (Insertion and Removal) |
92.9; 74.1; 91.3; 88.6; 94.8; 93.9 | — |
| SECONDARY Subjective Response for Dryness |
80.6; 81.6; 76.4 | — |
| SECONDARY Overall Satisfaction, Vision |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Overall Satisfaction, Comfort |
0; 0; 0; 3; 1; 5 | — |
| SECONDARY Overall Satisfaction, Handling |
0; 0; 0; 1; 4; 4 | — |
| SECONDARY Overall Satisfaction, Dryness |
1; 0; 2; 4; 3; 5 | — |
| SECONDARY Overall Satisfaction |
0; 0; 1; 1; 1; 3 | — |
| SECONDARY Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up) |
3.5; 3.3; 3.4; 3.6; 3.2; 3.5 | — |
| SECONDARY Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up) |
0.0; 0.1; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.1 | — |
| SECONDARY Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up) |
0.3; 0.3; 0.3; 0.2; 0.3; 0.3 | — |
| SECONDARY Lens Fit and Performance - Fit Acceptance |
3.6; 3.6; 3.7; 3.6; 3.6; 3.7 | — |
| SECONDARY Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up) |
54.0; 56.0; 53.0; 58.0; 55; 54 | — |
| SECONDARY Ocular Health - Biomicroscopy |
0.88; 0.96; 0.95; 0.81; 0.96; 0.98 | — |
Eligibility Criteria
Inclusion Criteria
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft CL wearer
- Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 1.25 D spectacle cylinder in each eye.
- Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter
- Is willing to comply with the wear schedule (at least 3 full days)
- Is willing to comply with the visit schedule
Exclusion Criteria
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
- Has best corrected spectacle distance vision worse then 20/25 in either eye.
- Has any systemic disease affecting ocular health.
- Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
- Has any ocular pathology or severe insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars.
- Is aphakic.
- Is presbyopic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02097030). 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.