N/A
Completed N=170
Dispensing Evaluation of Investigational Contact Lenses
Myopia; Astigmatism
Source: ClinicalTrials.gov NCT02625220 ↗
Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 — 1.0 proportion of Subject Eyes
Summary
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eyes With Monocular Visual Acuity Better Than 20/40 |
1.0 | — |
| PRIMARY The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees |
0.993 | — |
| PRIMARY Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees |
1.0 | — |
| PRIMARY Proportion of Subject Eyes With Acceptable Lens Fit |
1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
- The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
- Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
- Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
- Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
- If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
- Subject's best corrected distance acuity must be 20/25-2 or better in each eye.
Exclusion Criteria
- Females who are currently pregnant or lactating.
- Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
- Habitual wearer of extended wear contact lenses.
- Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- History of seizures.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
- History of binocular vision abnormality or strabismus, by self-report.
- Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
- Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
- Any active ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
Data sourced from ClinicalTrials.gov (NCT02625220). 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.