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

Astigmatism Clinical Trial

Official title:

Clinical Evaluation of Biomedics 1 Day Toric and MyDay Toric

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05805085
• Other study ID #: EX-MKTG-146
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Lens A (Hydrogel Daily Disposable Toric Contact Lens)
15 minutes
• Lens B (Silicone Hydrogel Daily Disposable Toric Contact Lens)
15 minutes

Locations

Country	Name	City	State
Spain	Clinic of Optometry; Faculty of Optics and Optometry	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	15 minutes