Comparison of Two Toric Contact Lenses on Current Toric Wearers

NCT00639379 | Completed Results

• 1 other identifier: CR-0802
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Ametropia

Keywords

toric contact lenses; vision; comfort; toric fit characteristics; slit lamp findings

Outcome Measures

Primary Outcomes (5)

• Lens Orientation Within 5 Degrees

  Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

  1 minute after insertion

• Lens Stability

  Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.

  10-15 minutes after insertion

• Subjective Lens Comfort

  A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable.

  1 and 2 weeks

• Subjective Vision

  A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.

  1 and 2 weeks

• Overall Corneal Staining

  Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

  after 2 weeks use

Study Arms (2)

senofilcon A

EXPERIMENTAL

senofilcon A toric daily wear contact lenses

Device: senofilcon A toric

alphafilcon A

ACTIVE COMPARATOR

alphafilcon A toric daily wear contact lenses

Device: alphafilcon A toric

Interventions

senofilcon A toric DEVICE

silicone hydrogel toric lens, 2 wk replacement, daily wear

Also known as: ACUVUE OASYS

senofilcon A

alphafilcon A toric DEVICE

hydrogel toric lens, 2 wk replacement, daily wear

Also known as: SofLens Toric

alphafilcon A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (7)

Ted Brink and Associates

Jacksonville, Florida, 32256, United States

Location

Eola Eyes

Orlando, Florida, 32801, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

The Koetting Associates Inc.

St Louis, Missouri, 63144, United States

Location

Southern Eyes

Concord, North Carolina, 28025, United States

Location

Western Reserve Vision Care

Beachwood, Ohio, 44122, United States

Location

Primary Eyecare Group, P.C.

Brentwood, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Kurt Moody, OD
• Organization: Vistakon

904-443-3088

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 20, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 21, 2015
• Results First Posted: July 19, 2010

Record last verified: 2015-05

Locations

US (7)