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N/A Completed N=47 Single-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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