Clinical Evaluation of Two Toric Contact Lenses

NCT05688657 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-137
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Subjective Handling Ratings on Insertion

  Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance

  At insertion

Study Arms (2)

Lens A

EXPERIMENTAL

All participants wore Lens A for 15 minutes (Period 1)

Device: Lens A

Lens B

EXPERIMENTAL

All participants wore Lens B for 15 minutes (Period 2)

Device: Lens B

Interventions

Lens A DEVICE

Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear

Lens A

Lens B DEVICE

Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear

Lens B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 -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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Dr. Ruben Velazquez Private Practice

Mexico City, 06700, Mexico

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

jvega2@coopervision.com

925-621-3761

Study Officials

• Rubén V Guerrero, MSc., FIACLE

  Dr. Ruben Velazquez Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: All participants received Lens A and then Lens B in fixed-sequence order.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: October 22, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 20, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-01

Locations

ME (1)