Clinical Evaluation of Two Toric Contact Lenses

Clinical Evaluation of Clariti Monthly Toric and Clariti 1 Day Toric

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lens A; Device: Lens B

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06700
    • Dr. Ruben Velazquez Private Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A; All participants wore Lens A for 15 minutes (Period 1)	Device: Lens A; Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear
Experimental: Lens B; All participants wore Lens B for 15 minutes (Period 2)	Device: Lens B; Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Handling Ratings on Insertion	Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance	At insertion

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Rubén V Guerrero, MSc., FIACLE, Dr. Ruben Velazquez Private Practice

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes