Clinical trial NCT06490302: Clinical Evaluation of Two Toric Soft Contact Lenses
Official title: Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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:

  1. Pathological dry eye or associated findings
  2. Pterygium, pinguecula, or corneal scars within the visual axis
  3. Neovascularization \> 0.75 mm in form of the limbus
  4. Giant papillary conjuctivitis (GCP) worse than grade 1
  5. Anterior uveitis or iritis (past or present)
  6. Seborrheic eczema, seborrheic conjunctivitis
  7. History of corneal ulcers or fungal infections
  8. Poor personal hygiene
  9. Has a know history of corneal hypoesthesia (reduced corneal sensitivity)
  10. Has aphakia, kertaoconus or a highly irregular cornea.
  11. Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  12. Has undergone corneal refractive surgery.
  13. Is participating in any other type of eye related clinical or research study.

Primary outcomes:
measure: Lens Fit Acceptance Ratings
timeFrame: At the end of 15 minutes of daily wear
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Consultorio Optométrico Queretaro
Study officials:
affiliation: National Autonomous University
name: Ruben Guerrero, MSc, FIACLE
role: PRINCIPAL_INVESTIGATOR
References: