MedPath

Clinical Evaluation of Two Toric Contact Lenses

Not Applicable
Completed
Conditions
Astigmatism
Interventions
Device: Lens A
Device: Lens B
Registration Number
NCT05688657
Lead Sponsor
Coopervision, Inc.
Brief Summary

The study objective was to compare short-term clinical performance data of two toric contact lenses.

Detailed Description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of a monthly toric contact lens when compared to a daily disposable toric contact lens after 15 minutes of daily wear each.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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 +4.00 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 -2.25 D 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.
  • 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 -2.50 D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 2-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  • 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 from of the limbus
  • Giant papillary conjunctivitis (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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Lens ALens AAll participants wore Lens A for 15 minutes (Period 1)
Lens BLens BAll participants wore Lens B for 15 minutes (Period 2)
Primary Outcome Measures
NameTimeMethod
Subjective Handling Ratings on InsertionAt insertion

Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dr. Ruben Velazquez Private Practice

🇲🇽

Mexico City, Mexico

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