N/A
N=144
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01729208 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Refractive Error Relative to Baseline — -0.18; -0.58 Diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dual Focus Soft Contact Lens (Device); Single Vision Soft Contact Lens (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Refractive Error Relative to Baseline |
-0.51; -1.24 | — |
| PRIMARY Change in Refractive Error Relative to Baseline |
-0.51; -1.24 | — |
| PRIMARY Change in Refractive Error Relative to Baseline |
-0.51; -1.24 | — |
| PRIMARY Change in Axial Length Relative to Baseline |
0.30; 0.62 | — |
| PRIMARY Change in Axial Length Relative to Baseline |
0.30; 0.62 | — |
| PRIMARY Change in Axial Length Relative to Baseline |
0.30; 0.62 | — |
| SECONDARY Number of Participants With Biomicroscopic Findings Greater Than Grade 2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Biomicroscopic Findings Greater Than Grade 2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Biomicroscopic Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Biomicroscopic Findings Greater Than Grade 2. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Incidence of Adverse Events |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Incidence of Adverse Events |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Incidence of Adverse Events |
0; 1; 0; 1; 0; 1 | — |
Summary
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Eligibility Criteria
Inclusion Criteria
- Be between 8 and 12 years of age inclusive.
- Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
- Spherical Equivalent Refractive Error between -0.75 and -4.00 D
- inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
- Possess wearable and visually functional eyeglasses.
- Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.
Exclusion Criteria
- Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
- Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
- Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
- Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
- A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
Data sourced from ClinicalTrials.gov (NCT01729208). 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.