Clinical trial NCT01857102: Toric Eye Strain and Stability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.


Eligibility criteria: Inclusion Criteria:

1. The subject must have read, understand, and sign the statement of informed consent and receive a fully executed copy of the Informed Consent Form.
2. The subject must appear able and willing to adhere to the instructions set forth in this protocol.
3. The subject must be between 18 years and 45 years of age (inclusive).
4. The subject must have best-corrected Snellen visual acuity of 20/30 or better in each eye.
5. If the subject has ever worn contact lenses, the subject must be a current wearer of soft spherical contact lenses for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
6. Subjective refraction must result in a vertex-corrected astigmatic contact lens prescription requiring at least -0.75 DC but not more than -1.75 DC cylindrical contact lens correction in each eye.
7. Subjective refraction must result in a vertex-corrected spherical contact lens prescription between +0.25D to +4.00D or between-0.50D to -9.00D in each eye.
8. The subject must not have the need for presbyopic correction (i.e., they must not be using as add in spectacles or wearing multifocal or monofocal contact lenses).
9. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
10. The subject must have access to the internet throughout the day (either desktop and/or smartphone) and be willing to answer a web-based survey within 1 hour of receiving a text message based notification throughout the day for up to 8 days, throughout the study duration.

Exclusion Criteria:

1. Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued)
2. Any previous ocular or intra-ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
3. Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. greater than or equal to grade 3 finding of edema, corneal neovascularization, corneal staining, conjunctival injection, blepharitis/meibomian gland dysfunction) on the FDA classification scale or any other ocular abnormality that in the opinion of the investigator may contraindicate contact lens wear.
4. Any ocular infection
5. Current use of topical ophthalmic medications other than artificial tears/rewetting drops.
6. History of binocular vision abnormality or strabismus.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
8. Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
9. Employee of the investigational clinic (e.g. investigator, coordinator, technician)
10. Subject does not have a wearable pair of spectacles.

Primary outcomes:
measure: Objective Comfort Assessed by Electromyography(EMG)
timeFrame: 1 week
measure: Visual Comfort
timeFrame: 1-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
References: