Performance of Two Toric Silicone Hydrogel Contact Lenses

NCT03578926 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-93
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (6)

• Lens Centration

  Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

  Baseline

• Lens Centration

  Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

  2 weeks

• Corneal Coverage

  Lens covering the cornea (Yes, No)

  Baseline

• Corneal Coverage

  Lens covering the cornea (Yes, No)

  2 weeks

• Post Blink Movement

  Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

  Baseline

• Post Blink Movement

  Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

  2 weeks

Secondary Outcomes (2)

• Wearing Time

  2 weeks

• Comfortable Wearing Time

  2 weeks

Study Arms (2)

fanfilcon A toric lens

EXPERIMENTAL

Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.

Device: fanfilcon A toric lens

senofilcon A toric lens

ACTIVE COMPARATOR

Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.

Device: senofilcon A toric lens

Interventions

fanfilcon A toric lens DEVICE

contact lens

Also known as: Avaira Vitality toric lens

fanfilcon A toric lens

senofilcon A toric lens DEVICE

contact lens

Also known as: Acuvue Oasys for Astigmatism

senofilcon A toric lens

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
• Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
• Have 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)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSc., FAAO
• Organization: CooperVision Inc.

javega@coopervision.com

9256213761

Study Officials

• Ruben Velázquez Guerrero, MSc., FIACLE

  School of Optometry, National Autonomous University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked (participant and investigator)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: June 18, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)