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N/A Completed N=40 Single-blind Treatment

Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses

Astigmatism
Source: ClinicalTrials.gov NCT05805085 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Subjective Handling at Insertion, Dispensing Visit — 87.13; 88.50 score on a scale

Summary

This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Outcome Measures

OutcomeResultp-value
PRIMARY
Subjective Handling at Insertion, Dispensing Visit
87.13; 88.50
PRIMARY
Subjecting Handling at Insertion, Follow-up Visit
92.63; 90.13

Eligibility Criteria

Inclusion Criteria

A person was eligible for inclusion in the study if he/she:

  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and signed an information consent letter.
  • Self-reports having a full eye examination in the previous two years.
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
  • Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
  • Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease.
  • Has read, understood, and signed the information consent letter.

Exclusion Criteria

A person was excluded from the study if he/she:

  • Is participating in any concurrent clinical or research study.
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear.
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study.
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
  • Has undergone refractive error surgery or intraocular surgery.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05805085). 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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