N/A
Completed N=40
Clinical Evaluation of Two Toric Soft Contact Lenses
Astigmatism
Source: ClinicalTrials.gov NCT06490302 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Overall Fit Acceptance — 3.6; 3.7 units on a scale
Summary
The aim of this study is to compare the short-term clinical performance of two toric contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Fit Acceptance |
3.6; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years.
- Is an adapted soft contact lens wearer.
- Is not a habitual wearer of either study lens.
- Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
- Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D 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 informed consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, >8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule.
Exclusion Criteria
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in form of the limbus
- Giant papillary conjuctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT06490302). 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.