N/A
Completed N=171
Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
Visual Acuity
Source: ClinicalTrials.gov NCT02756078 ↗
Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Overall CLUE Comfort — 65.0; 60.3 Units on a Scale
Summary
This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall CLUE Comfort |
65.0; 60.3 | — |
| SECONDARY Overall CLUE Handling |
66.7; 52.9 | — |
| SECONDARY Time to Haze |
9.4; 9.7 | — |
| SECONDARY Average Wear Time |
11.5; 11.55 | — |
| SECONDARY Average Comfortable Wear Time |
9.6; 9.6 | — |
| SECONDARY Difference in Total Device Use Time and Comfortable Wear Time During Device Use |
1.2; 1.2 | — |
| SECONDARY Comfort at the End of the Day |
2.6; 2.7 | — |
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 and 40 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
- The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
- The subject must have best corrected visual acuity of 0.20 or better in each eye.
- The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
- The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
- The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
- The subject must meet normal eligibility conditions of binocular vision tests.
- The subject may not have any double vision at near with their habitual contact lens correction.
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 (at the investigator's discretion).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
- Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- Any active ocular infection.
- 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.).
- 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 known hypersensitivity or allergic reaction to the study products.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Data sourced from ClinicalTrials.gov (NCT02756078). 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.