Clinical trial NCT01180998: Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2010-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).


Eligibility criteria: Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

1. One of the following:

   1. Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day)
   2. Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day)
   3. Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses.
2. Between 16 and 60 years of age.
3. Have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
4. Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive)
5. Refractive astigmatism between -0.75D and -3.00D in both eyes.
6. Have best corrected VA of 6/9 (20/30) or better in each eye.
7. Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

   1. No amblyopia.
   2. No evidence of lid abnormality or infection.
   3. No conjunctival abnormality or infection.
   4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, vascularisation, infiltrates or abnormal opacities).
   5. No other active ocular disease.
8. Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only)

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

1. Requires concurrent ocular medication.
2. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
3. Corneal staining Grade 3 in more than two regions.
4. Extended wear in the last 3 months.
5. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
6. Abnormal lachrymal secretions.
7. Pre-existing ocular irritation that would preclude contact lens fitting.
8. Keratoconus or other corneal irregularity.
9. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
10. Has diabetes.
11. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
12. Pregnancy, lactating, or planning a pregnancy at the time of enrollment.
13. Participation in any concurrent clinical trial or in last 60 days.

Primary outcomes:
measure: Overall Success in Fitting With a Toric Contact Lens
timeFrame: 4 weeks
measure: Distance Visual Acuity
timeFrame: after 1 week of toric contact lens wear
measure: Distance Visual Acuity (VA)
timeFrame: after 4 weeks of toric contact lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
state: Berkshire
city: Marlow
country: United Kingdom
state: Bucks
city: Broadstone
country: United Kingdom
state: Dorset
city: Portchester
country: United Kingdom
state: Hampshire
city: Southsea
country: United Kingdom
state: Hampshire
city: St. Albans
country: United Kingdom
state: Herts
city: Shanklin
country: United Kingdom
state: Isle Of Wight
city: Rawtenstall
country: United Kingdom
state: Lancashire
city: Hendon
country: United Kingdom
state: London
city: Pinner
country: United Kingdom
state: Middlesex
city: Teddington
country: United Kingdom
state: Middlesex
city: Uxbridge
country: United Kingdom
state: Middlesex
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Croydon
country: United Kingdom
state: Surrey
city: Coventry
country: United Kingdom
state: West Midlands
city: Birmingham
country: United Kingdom
city: Bristol
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
References: