N/A
N=81
Clinical Characterization of Symptomatic Populations
Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT03319212 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Meibomian Gland Imaging — 10; 4; 23; 66 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Meibomian Gland Imaging |
10; 4; 23; 66; 18; 16 | — |
| PRIMARY Meibomian Gland Expressibility |
9.04; 8.07; 8.71; 7.94; 7.94; 6.54 | — |
| PRIMARY Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings |
1; 5; 12; 21; 12; 33 | — |
| PRIMARY Lid Wiper Epitheliopathy |
0.50; 0.28 | — |
| PRIMARY Conjunctival Folds |
27; 45; 22; 41; 3; 8 | — |
| SECONDARY Conjunctival Redness |
12; 11; 36; 72; 6; 13 | — |
| SECONDARY Conjunctival Staining |
17; 17; 18; 51; 19; 28 | — |
| SECONDARY Corneal Staining |
51; 88; 1; 5; 2; 3 | — |
| SECONDARY Tear Film Lipid Layer Thickness |
66.81; 63.00 | — |
| SECONDARY Tear Film Stability |
8.03; 6.78 | — |
| SECONDARY Tear Film Lipid Pattern |
0; 0; 6; 24; 18; 22 | — |
Summary
This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.
Eligibility Criteria
Inclusion Criteria
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 18 and 55 (inclusive) years of age at the time of screening.
- Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.
- Have a baseline CLDEQ-8 score of either:
- 7 or lower
- 15 or greater
- Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
- Subjects must pass a pre-screening questionnaire.
- Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
- Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.
Exclusion Criteria
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating, by self-report.
- Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
- Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
- Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
- Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
Data sourced from ClinicalTrials.gov (NCT03319212). 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.