Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study

NCT00804505 | Completed

• 1 other identifier: SI-0804 V1.0
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:

• within the corresponding range of lens powers
• in a population randomized within multiple investigational sites
• with a study ration of 2/1 test vs control lenses
• for a duration of 90 days.

Conditions

Corneal Disease; Hypersensitivity

Keywords

Substantial equivalence to control device

Outcome Measures

Primary Outcomes (2)

• Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control

  3 months

• Visual acuity comparison test/control.

  3 mo.

Study Arms (2)

1

EXPERIMENTAL

Test arm daily wear hybrid contact lens.

Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens

2

OTHER

Control: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Hybrid Contact Lens

Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens

Interventions

SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens DEVICE

Comparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days.

1

SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens DEVICE

Comparison to test lens: Daily use for minimum 8 hours up to 90 days.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior to being considered eligible to participate in this study, each subject MUST:
• Be at least 18 years of age as of the date of evaluation.
• Have
• read the Informed Consent,
• been given an explanation of the Informed Consent,
• indicated an understanding of the Informed Consent and
• signed the Informed Consent Form.
• Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
• Be a current contact lens wearer.
• Possess wearable and visually functional eyeglasses.
• Be in good general health, based on his/her knowledge.
• Require spectacle lens powers between plano and -6.00 diopters sphere with no more than -2.50 diopters of spectacle refractive astigmatism and be willing to wear lenses in both eyes.
• Have manifest refraction visual acuity equal to or better than 20/25 in each eye.

You may not qualify if:

• Subjects may not be enrolled into the study if ANY of the following apply:
• Subject is wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may NOT wear monovision lenses at any time during the study as it will interfere with the distance visual acuity measurement.
• Subject exhibits poor personal hygiene.
• Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
• Subject is currently pregnant (to the best of the subject's knowledge), is planning a pregnancy within the next 3 months or is lactating.
• Subject is a member, relative or household member of the office staff, including the investigator(s).
• Subject has a known sensitivity to ingredients used in contact lens care products or over-the-counter lubricants and artificial tears.
• Subject has undergone refractive surgery or is currently receiving or has previously received orthokeratology treatment.
• Subject is aphakic or pseudophakic.
• Subject has ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome lupus erythematosus, scleroderma, keratoconus or type II diabetes.
• Use of ocular medications for any reason or systemic medications which might interfere with contact lens wear.
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
• History of corneal ulcer, corneal infiltrates or fungal infections
• Corneal scars within the visual axis

Sponsors & Collaborators

• SynergEyes, Inc.: lead

Study Sites (8)

Carmel Mountain Vision Care

San Diego, California, 92129, United States

Location

Silicon Valley Eye Physicians

Sunnyvale, California, 94087, United States

Location

Casazza Optometric Group

Andover, Massachusetts, 01810, United States

Location

Vision Care Associates

East Lansing, Michigan, 48823, United States

Location

Western Reserve Vision Care, Inc.

Beachwood, Ohio, 44122, United States

Location

Dr. Karambelas & Associates

Providence, Rhode Island, 02906, United States

Location

Primary Eyecare Group P.C.

Brentwood, Tennessee, 37027, United States

Location

Snowy Range Vision Center

Laramie, Wyoming, 82070, United States

Location

MeSH Terms

Conditions

Corneal Diseases; Hypersensitivity

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Eye Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• William Gleason, OD

  Foresight Regulatory Strategies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

US (8)