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Bifocal Lenses In Nearsighted Kids
NA trial testing Biofinity Multifocal D +1.50 add in Refractive Errors in 294 participants. Completed in 24 June 2019.
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 294 |
| Start date | 22 September 2014 |
| Primary completion | 24 June 2019 |
| Estimated completion | 24 June 2019 |
| Sites | 2 locations across United States |
Ohio State University
Adults 7 to 11, any sex, with Refractive Errors. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | -3.46 | ± 1.20 |
| Biofinity +1.50 D Add | -3.32 | ± 1.48 |
| Biofinity +2.50 D Add | -2.84 | ± 1.22 |
The outcome of interest is the change in ocular shape and measured by the change in peripheral refractive error in the right eye. The change in peripheral refractive error will be compared among the two treatment groups and the control group to determine whether peripheral defocus changes the shape of the eye globally (across the whole eye) or locally (specific to the region of the eye affected by the defocus).
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.92 | ± 0.85 |
| Biofinity +1.50 D Add | 24.94 | ± 0.97 |
| Biofinity +2.50 D Add | 24.64 | ± 0.79 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.86 | ± 0.87 |
| Biofinity +1.50 D Add | 24.90 | ± 1.09 |
| Biofinity +2.50 D Add | 24.60 | ± 0.93 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.98 | ± 0.89 |
| Biofinity +1.50 D Add | 24.98 | ± 0.97 |
| Biofinity +2.50 D Add | 24.74 | ± 0.84 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.98 | ± 0.89 |
| Biofinity +1.50 D Add | 24.98 | ± 0.97 |
| Biofinity +2.50 D Add | 24.71 | ± 0.84 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.64 | ± 0.83 |
| Biofinity +1.50 D Add | 24.68 | ± 0.94 |
| Biofinity +2.50 D Add | 24.45 | ± 0.78 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.70 | ± 0.84 |
| Biofinity +1.50 D Add | 24.79 | ± 1.01 |
| Biofinity +2.50 D Add | 24.51 | ± 0.87 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.76 | ± 0.92 |
| Biofinity +1.50 D Add | 247.77 | ± 0.95 |
| Biofinity +2.50 D Add | 24.58 | ± 0.86 |
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 24.30 | ± 0.82 |
| Biofinity +1.50 D Add | 24.29 | ± 0.91 |
| Biofinity +2.50 D Add | 24.04 | ± 0.81 |
Peripheral defocus will be measured in 10 areas (Nasal and temporal zones at 20, 30, and 40 degrees, and superior and inferior zones at 20 and 30 degrees) and analyzed for its relation to myopia progression (as measured by cycloplegic autorefraction in the right eye only).
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | -1.01 | ± 0.66 |
| Biofinity +1.50 D Add | -0.85 | ± 0.82 |
| Biofinity +2.50 D Add | -0.56 | ± 0.66 |
Axial length progression, as measured by Lenstar in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).
| Group | Value | 95% CI |
|---|---|---|
| Biofinity | 25.08 | ± 0.85 |
| Biofinity +1.50 D Add | 25.12 | ± 0.97 |
| Biofinity +2.50 D Add | 24.81 | ± 0.83 |
Time frame: Three years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Biofinity | Biofinity +1.50 D Add | Biofinity +2.50 D Add |
|---|---|---|---|---|
| Solution induced corneal staining | Eye disorders | — | — | — |
| Ocular allergies | Eye disorders | — | — | — |
| Trauma, non-ocular | General disorders | — | — | — |
| Systemic disease | General disorders | — | — | — |
| Hordeolum/chalazion | Eye disorders | — | — | — |
| Headaches | General disorders | — | — | — |
| Corneal epithelial defect | Eye disorders | — | — | — |
| Infiltrative keratitis | Eye disorders | — | — | — |
| Giant papillary conjunctivitis | Eye disorders | — | — | — |
| Corneal scar, new | Eye disorders | — | — | — |
| Dry eye | Eye disorders | — | — | — |
| Contact lens solution issue | Eye disorders | — | — | — |
| Conjunctivitis, any type | Eye disorders | — | — | — |
| Binocular vision/accommodation issue | Eye disorders | — | — | — |
| Toxic exposure | Eye disorders | — | — | — |
| Retinal issue | Eye disorders | — | — | — |
| Concussion | General disorders | — | — | — |
| Mental health issues | Psychiatric disorders | — | — | — |
| SEAL | Eye disorders | — | — | — |
| Subconjunctival hemorrhage | Eye disorders | — | — | — |
| Trauma, ocular | Eye disorders | — | — | — |
| Unspecified contact lens issue | Eye disorders | — | — | — |
| Allergy, non-ocular | Immune system disorders | — | — | — |
| CLARE | Eye disorders | — | — | — |
| Blepharitis | Eye disorders | — | — | — |
| Foreign body | Eye disorders | — | — | — |
| Transient visual disturbance | Eye disorders | — | — | — |
| Probable microbial keratitis | Eye disorders | — | — | — |
| Sterile Corneal Ulcer | Eye disorders | — | — | — |
| Eyelash issue | Eye disorders | — | — | — |
| Ptosis | Eye disorders | — | — | — |
| Poor contact lens fit | Eye disorders | — | — | — |
| Optic nerve issue | Eye disorders | — | — | — |
| Uveitis | Eye disorders | — | — | — |
| Color vision defect | Eye disorders | — | — | — |
| Visual symptoms, no obvious cause | Eye disorders | — | — | — |
| Can't categorize | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT02255474 adverse events section.
This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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