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Clinical Evaluation of Hydrogel 1 Day Toric and Silicone Hydrogel Daily Disposable Toric

Primary Purpose

Astigmatism

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lens A (Hydrogel Daily Disposable Toric Contact Lens)
Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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 plano to -10.00 (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 -1.75D 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: A person was excluded from the study if he/she: 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 -1.75D 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.

Sites / Locations

  • Clinic of Optometry; Faculty of Optics and Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lens A

Lens B

Arm Description

Participants will wear Lens A for the first period of 15 minutes.

Participants will wear Lens B for the second period of 15 minutes.

Outcomes

Primary Outcome Measures

Subjective handling ratings on insertion
Subjective handling ratings on insertion will be assessed using 0-100 scale (100=Excellent, very easy; 0=Very difficult to manage)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05805085
Brief Title
Clinical Evaluation of Hydrogel 1 Day Toric and Silicone Hydrogel Daily Disposable Toric
Official Title
Clinical Evaluation of Biomedics 1 Day Toric and MyDay Toric
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
Detailed Description
This is a subject masked, interventional, prospective, direct refit, bilateral wear study to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear. Participants will wear LENS A first, followed by LENS B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lens A
Arm Type
Experimental
Arm Description
Participants will wear Lens A for the first period of 15 minutes.
Arm Title
Lens B
Arm Type
Experimental
Arm Description
Participants will wear Lens B for the second period of 15 minutes.
Intervention Type
Device
Intervention Name(s)
Lens A (Hydrogel Daily Disposable Toric Contact Lens)
Intervention Description
15 minutes
Intervention Type
Device
Intervention Name(s)
Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)
Intervention Description
15 minutes
Primary Outcome Measure Information:
Title
Subjective handling ratings on insertion
Description
Subjective handling ratings on insertion will be assessed using 0-100 scale (100=Excellent, very easy; 0=Very difficult to manage)
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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 plano to -10.00 (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 -1.75D 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: A person was excluded from the study if he/she: 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 -1.75D 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan G Carracedo Rodríguez, OD, MSc, PhD
Organizational Affiliation
University Complutense of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Optometry; Faculty of Optics and Optometry
City
Madrid
ZIP/Postal Code
28037
Country
Spain

12. IPD Sharing Statement

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Clinical Evaluation of Hydrogel 1 Day Toric and Silicone Hydrogel Daily Disposable Toric

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