Phase 4
Completed N=71
Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
Contact Lens Base Curve (BC) Fit and Comfort
Source: ClinicalTrials.gov NCT02537522 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Correlation Between Subjective CLUE Comfort and Keratometry — 0.042; 0.004; -0.001; -0.002 Pearson Correlation
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Subjective CLUE Comfort and Keratometry |
0.042; 0.004; -0.001; -0.002 | — |
| PRIMARY Correlation Between Subjective CLUE Comfort and Corneal Diameter |
0.011; -0.086; 0.021; -0.119 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
- The subject must be willing and able to adhere to the instructions set out in the protocol.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be willing to wear the study contact lenses up to 14 hours/day.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
- The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- Current 1-DAY ACUVUE® TruEye® wearers
- Anisometropia of 1.00 D or greater
- Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
- Pregnancy or lactation
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Data sourced from ClinicalTrials.gov (NCT02537522). 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.