N/A
Completed N=15
A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
Refractive Error · Myopia
Source: ClinicalTrials.gov NCT02066922 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Change in Average Central Corneal Curvature From Dispense at Week 1 — -0.44; -0.11 diopters
Summary
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Central Corneal Curvature From Dispense at Week 1 |
-0.44; -0.11 | — |
| SECONDARY Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 |
3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent document;
- Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
- Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
- Manifest astigmatism less than or equal to -1.00D;
- Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Pregnant or lactating;
- Eye injury or surgery within twelve weeks immediately prior to enrollment;
- Any ocular condition that contraindicates contact lens wear;
- History of herpetic keratitis;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
- Clinical significant dry eye not responding to treatment;
- Previous corneal or refractive surgery or irregular cornea;
- Requires reading glasses;
- Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;
- Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02066922). 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.