N/A
Completed N=47
A Clinical Comparison of Two Soft Multifocal Contact Lenses
Source: ClinicalTrials.gov NCT05794126 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Subjective Overall Score — 71.4; 80.3 score on a scale
Summary
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Overall Score |
71.4; 80.3 | — |
| SECONDARY Subjective Comfort |
75.0; 88.9 | — |
| SECONDARY Subjective Vision |
72.3; 78.4; 77.4; 79.6 | — |
Eligibility Criteria
Inclusion Criteria
- They were at least 42 years of age and had capacity to volunteer.
- They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- They had had a full eye examination within the past two years (by self-report).
- They were willing and able to follow the protocol.
- They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
- They had refractive astigmatism of no greater than -0.75DC.
- They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.
Exclusion Criteria
Subjects were not eligible to take part in the study if:
- They had an ocular disorder which would normally contra-indicate contact lens wear.
- They had a systemic disorder which would normally contra-indicate contact lens wear.
- They were using any topical medication such as eye drops or ointment.
- They were aphakic.
- They had had corneal refractive surgery.
- They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
- They were pregnant or lactating.
- They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
Data sourced from ClinicalTrials.gov (NCT05794126). 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.