N/A
N=25
Contact Lens Adaptation in Neophytes
Contact Lens Comfort
Bottom Line
View on ClinicalTrials.gov: NCT02148263 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) — 10.8; 16.3 Units on a Scale — p=0.83
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI) |
10.8; 16.3 | 0.83 |
| SECONDARY Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart |
0.03; 0.01 | 0.95 |
| SECONDARY Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT) |
11.7; 9.8 | .94 |
| SECONDARY Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH) |
0.31; 0.32 | .96 |
| SECONDARY Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M |
0.69; 0.59 | .14 |
| SECONDARY Between-Group Difference in Upper and Lower Eyelid Blepharitis |
1.1; 1.3; 0.4; 0.8 | .27 |
| SECONDARY Between-Group Difference in Corneal Sodium Fluorescein Staining |
0.0; 0.3; 0.0; 0.2; 0.0; 0.2 | .50 |
| SECONDARY Between-Group Difference in Tear Volume as Measured by Schirmer's Test I |
15.9; 21.2 | 0.32 |
| SECONDARY Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS) |
89.0; 81.8 | 0.47 |
| SECONDARY Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores |
— | — |
Summary
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
Eligibility Criteria
Inclusion Criteria
- Has had a completed comprehensive eye exam within the past 6 months
- Able to wear spherical senofilcon A contact lenses
- Able to use Opti-Free PureMoist contact lens solution
Exclusion Criteria
- Any prior contact lens use
- Topical eye drops within the last two hours of the study visit
- Known systemic health conditions known to alter tear film physiology
- History of severe ocular trauma
- Active ocular infection
- Active ocular inflammation
- Known hypersensitivity to diagnostic eye drops
- Pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT02148263). 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.