N/A
Completed N=150
Clinical Evaluation of Approved and Investigational Contact Lenses
Visual Disorder
Source: ClinicalTrials.gov NCT02669095 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Acceptable Lens Fitting — 1; 0.99 Proportion of eyes
Summary
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptable Lens Fitting |
1; 0.99 | — |
| PRIMARY Overall Comfort |
71.75; 56.68; 70.58; 54.69; 68.75; 53.43 | — |
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 appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 18 to 40 years of age at the time of consent.
- The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
- Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
- The subject must have best corrected visual acuity of 20/30 or better in each eye.
- The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT02669095). 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.