N/A
Completed N=40
A Clinical Performance of Two Soft Toric Contact Lenses
Astigmatism
Source: ClinicalTrials.gov NCT05633082 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Subjective Overall Score — 71.6; 78.9 score on a scale
Summary
The study objective was to gather short-term clinical performance data for two soft toric contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Overall Score |
71.6; 78.9 | — |
| SECONDARY Subjective Comfort |
74.6; 85.0 | — |
| SECONDARY Subjective Vision |
76.6; 78.8 | — |
Eligibility Criteria
Inclusion Criteria
- They are of legal age (18) and capacity to volunteer.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They currently wear soft contact lenses, or have done so within the past two years.
- They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
- They are expected to be able to be fitted with the study lenses within the power range available.
Exclusion Criteria
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or lactating.
- They have an eye or health condition including an immunosuppressive or infectious disease which would, 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 have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT05633082). 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.