Comparison of Two Toric Contact Lenses on Current Toric Wearers - Full Text View

Sponsored by:	Vistakon
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00639379

Purpose

The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity

Condition	Intervention
Vision Correction	Device: senoficlon A toric Device: alphafilcon A toric

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment
Official Title:	A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens

Further study details as provided by Vistakon:

Primary Outcome Measures:

Orientation: Orientation position (° @ 1m, 3m & settled); orientation stability (°); speed to reach orientation position (min) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual acuity (Snellen VA to nearest letter) [ Time Frame: 30 minutes and 2 weeks ] [ Designated as safety issue: Yes ]
General contact lens fit [ Time Frame: 30 minutes and 2 weeks ] [ Designated as safety issue: No ]
Slit Lamp Findings [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: Yes ]
Subjective Comfort [ Time Frame: 1 and 2 weeks ] [ Designated as safety issue: No ]
Subjective vision [ Time Frame: 1 and 2 weeks ] [ Designated as safety issue: No ]
Corneal staining by corneal sector (NEI scale) [ Time Frame: after 2 weeks use ] [ Designated as safety issue: Yes ]

Enrollment:	89
Study Start Date:	February 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental senofilcon A toric	Device: senoficlon A toric silicone hydrogel toric lens, 2 wk replacement
2: Active Comparator alphafilcon A toric	Device: alphafilcon A toric hydrogel toric lens, 2 wk replacement

Detailed Description:

Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:

Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses.
Be able and willing to adhere to the instructions set forth in the protocol.
Agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
Have a distance spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).
Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
Be in good general health, based on his/her knowledge.
Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.

Exclusion Criteria:

Presbyopic or has the need for a near add for reading.
Previous refractive surgery; current or previous orthokeratology treatment.
Aphakia, keratoconus or a highly irregular cornea.
The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Anterior uveitis or iritis (past or present).
A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium or corneal scars within the visual axis
- Neovascularization >1mm in from the limbus
- History of giant papillary conjunctivitis (GPC) worse than Grade 2
- Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis
Current pregnancy or lactation (to the best of the subject's knowledge).
Actively participating in another clinical study at any time during this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639379

Locations

United States, Florida
Eola Eyes
Orlando, Florida, United States, 32801
Ted Brink and Associates
Jacksonville, Florida, United States, 32256
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, Missouri
The Koetting Associates Inc.
St Louis, Missouri, United States, 63144
United States, North Carolina
Southern Eyes
Concord, North Carolina, United States, 28025
United States, Ohio
Western Reserve Vision Care
Beachwood, Ohio, United States, 44122
United States, Tennessee
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States, 37027

Sponsors and Collaborators

Vistakon

More Information

Responsible Party:	Foresight Regulatory Strategies, Inc. ( Dr. William Gleason )
Study ID Numbers:	CR-0802
Study First Received:	March 13, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00639379
Health Authority:	United States: Institutional Review Board

Keywords provided by Vistakon:

toric contact lenses
vision
comfort
toric fit characteristics
slit lamp findings

Study placed in the following topic categories:

Signs and Symptoms

ClinicalTrials.gov processed this record on January 16, 2009