Performance of Toric Silicone Hydrogel Contact Lenses

NCT05097144 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-128
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.

Conditions

Astigmatism; Myopia

Outcome Measures

Primary Outcomes (1)

• Lens Handling (Insertion and Removal)

  Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.

  1 month

Study Arms (2)

Lens A, then Lens B

EXPERIMENTAL

Participants wore Lens A for one month and then wore Lens B for one month.

Device: Lens A (fanfilcon A); Device: Lens B (asmofilcon A)

Lens B, then Lens A

EXPERIMENTAL

Participants wore Lens B for one month and then wore Lens A for one month.

Device: Lens A (fanfilcon A); Device: Lens B (asmofilcon A)

Interventions

Lens A (fanfilcon A) DEVICE

Daily wear for one month

Lens A, then Lens B; Lens B, then Lens A

Lens B (asmofilcon A) DEVICE

Daily wear for one month

Lens A, then Lens B; Lens B, then Lens A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 - 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 -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

You may not qualify if:

• A person will be excluded from the study if he/she:
• 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 -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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

National Autonomous University (UNAM)

Mexico City, Código, 54090, Mexico

Location

MeSH Terms

Conditions

Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega OD, MSc, FAAO
• Organization: CooperVision Inc.

JVega2@coopervision.com

9256213761

Study Officials

• Rubén Velázquez Guerrero, MSc, FIACLE

  National Autonomous University (UNAM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: August 21, 2021
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: October 17, 2023
• Results First Posted: August 24, 2022

Record last verified: 2022-10

Locations

ME (1)