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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05805085
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.2
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

This study is to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Lens A (Hydrogel Daily Disposable Toric Contact Lens); Device: Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)	N/A

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.

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 Biomedics 1 Day Toric and MyDay Toric
• Actual Study Start Date: Feb 22, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lens A Participants will wear Lens A for the first period of 15 minutes.	Device: Lens A (Hydrogel Daily Disposable Toric Contact Lens); 15 minutes
Experimental: Lens B Participants will wear Lens B for the second period of 15 minutes.	Device: Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens); 15 minutes

Outcome Measures

Primary Outcome Measures

1. Subjective handling ratings on insertion [15 minutes]

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

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic of Optometry; Faculty of Optics and Optometry	Madrid		Spain	28037

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Juan G Carracedo Rodríguez, OD, MSc, PhD, University Complutense of Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT05805085
• Other Study ID Numbers: EX-MKTG-146
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 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 Apr 7, 2023