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Clinical Evaluation of Two Toric Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05688657
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
31.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Monthly Replacement Toric Silicone Hydrogel Contact Lens A
  • Device: Daily Disposable Toric Silicone Hydrogel Contact Lens B
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Clariti Monthly Toric and Clariti 1 Day Toric
Actual Study Start Date :
Oct 22, 2022
Actual Primary Completion Date :
Nov 30, 2022
Actual Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monthly Replacement Toric Silicone Hydrogel Contact Lens A

Subjects will wear Monthly Replacement Toric Silicone Hydrogel Contact Lens A for the first period of 15 minutes and Daily Disposable Toric Silicone Hydrogel Contact Lens B for the second period of 15 minutes.

Device: Monthly Replacement Toric Silicone Hydrogel Contact Lens A
Monthly Replacement Toric Silicone Hydrogel Contact Lens A - first period of 15 minutes
Active Comparator: Daily Disposable Toric Silicone Hydrogel Contact Lens B

Subjects will wear Daily Disposable Toric Silicone Hydrogel Contact Lens B for the second period of 15 minutes.

Device: Daily Disposable Toric Silicone Hydrogel Contact Lens B
Daily Disposable Toric Silicone Hydrogel Contact Lens B - second period of 15 minutes

Outcome Measures

Primary Outcome Measures

  1. Subjective handling ratings on insertion [15 minutes]

    Subjective handling ratings on insertion will be measured on a scale from 0-10, where 10 = very easy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Ruben Velazquez Private Practice Mexico City Mexico 06700

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: RubĂ©n V Guerrero, MSc., FIACLE, Dr. Ruben Velazquez Private Practice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05688657
Other Study ID Numbers:
  • EX-MKTG-137
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
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
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Jan 18, 2023