Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear

NCT02847169 | Completed Results

• 1 other identifier: EX-MKTG-66
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric and ocufilcon D toric contact lenses after 1 week of wear in each pair.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (7)

• Overall Fit Acceptance

  Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect

  Baseline and 1 week

• Lens Centration

  Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).

  Baseline and 1 week

• Post-blink Movement

  Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.

  Baseline and 1 week

• Overall Stability

  Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.

  Baseline and 1 week

• Corneal Coverage

  Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)

  Baseline and 1 week

• Lens Orientation in Primary Position of Gaze

  Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.

  Baseline and 1 week

• Rotational Recovery in Degrees After 60 Seconds

  Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.

  Baseline and 1 week

Study Arms (2)

filcon IV1 toric lens

ACTIVE COMPARATOR

Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.

Device: filcon IV1 toric lens

ocufilcon D toric lens

ACTIVE COMPARATOR

Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.

Device: ocufilcon D toric lens

Interventions

filcon IV1 toric lens DEVICE

toric contact lens

filcon IV1 toric lens

ocufilcon D toric lens DEVICE

toric contact lens

ocufilcon D toric lens

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 toric 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 -2.00 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:
• 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 -2.00 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. Confidential EX-MKTG-66 Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear 10
• 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

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: Senior Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc.

javega@coopervision.com

925 621-3761

Study Officials

• Velázquez Guerrero, MSc., FIACLE

  School of Optometry, National Autonomous University (UNAM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: July 25, 2016
• First Posted: July 28, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)