Comparison of Two Toric Contact Lenses on Current Toric Wearers

Ametropia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639379
• Other study ID #: CR-0802
• Status: Completed
• Phase: N/A
• First received: March 13, 2008
• Last updated: May 5, 2015
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. 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).

2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.

3. Be a currently successful wearer for at least 3 months of B&L SofLens 66 Toric hydrogel lenses.

4. Be able and willing to adhere to the instructions set forth in the protocol.

5. 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.

6. 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).

7. Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.

8. Be in good general health, based on his/her knowledge.

9. 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:

1. Presbyopic or has the need for a near add for reading.

2. Previous refractive surgery; current or previous orthokeratology treatment.

3. Aphakia, keratoconus or a highly irregular cornea.

4. 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).

5. A known history of corneal hypoesthesia (reduced corneal sensitivity.)

6. Anterior uveitis or iritis (past or present).

7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.

8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.

9. 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

10. Current pregnancy or lactation (to the best of the subject's knowledge).

11. Actively participating in another clinical study at any time during this study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ametropia

Intervention

Device:
• senofilcon A toric
silicone hydrogel toric lens, 2 wk replacement, daily wear
• alphafilcon A toric
hydrogel toric lens, 2 wk replacement, daily wear

Locations

Country	Name	City	State
United States	Western Reserve Vision Care	Beachwood	Ohio
United States	Primary Eyecare Group, P.C.	Brentwood	Tennessee
United States	Southern Eyes	Concord	North Carolina
United States	Ted Brink and Associates	Jacksonville	Florida
United States	Clayton Eye Center	Morrow	Georgia
United States	Eola Eyes	Orlando	Florida
United States	The Koetting Associates Inc.	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No