N/A
Completed N=50
Clinical Comparison of Two Soft Contact Lenses
Source: ClinicalTrials.gov NCT06251154 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Subjective Overall Score — 80.2; 88.2 score on a scale
Summary
This study was designed to gather short-term clinical performance data for 2 soft contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Overall Score |
80.2; 88.2 | — |
| SECONDARY Subjective Comfort |
81.1; 90.4 | — |
| SECONDARY Subjective Vision |
81.9; 87.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will only be eligible for the study if:
- They were of legal age (18) and capacity to volunteer.
- They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- They were willing and able to follow the protocol.
- They were wearing soft contact lenses, or had done so within the past two years.
- They were able to be fitted with the study lenses within the power range available.
Exclusion Criteria
- Subjects will not be eligible 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.
- They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT06251154). 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.