Status:
COMPLETED
Clinical Evaluation of Two Toric Soft Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Astigmatism
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The aim of this study is to compare the short-term clinical performance of two toric contact lenses.
Detailed Description
The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06490302
Start Date
May 24 2024
End Date
June 28 2024
Last Update
August 22 2025
Active Locations (1)
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1
Consultorio Optométrico Queretaro
Mexico City, Mexico, 06760