Clinical trial NCT03278223: One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Official title: One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Keywords: Multipurpose Contact Lens Care System
Lead sponsor: OTE North America
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2017-09-11
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.

Detailed description: This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.

Eligibility criteria: Inclusion Criteria:

* Be a currently adapted soft contact lens wearer (\>1 month of lens wear).
* Be at least 18 years of age.
* Refractive astigmatism \<0.75 D in both eyes.
* Have clear corneas and be free of any anterior segment disorders.
* Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or better in each eye.
* Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).
* Require visual correction in both eyes (monovision allowed, no monofit).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  1. No amblyopia
  2. No strabismus
  3. No evidence of lid abnormality or infection
  4. No conjunctival abnormality or infection that would contraindicate contact lens wear
  5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  6. No other active ocular disease.

Exclusion Criteria:

* Require toric or multifocal contact lenses.
* Previously shown a sensitivity to any of the study solution components.
* Any systemic or ocular disease or allergies affecting ocular health.
* Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
* Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
* Keratoconus or other corneal irregularity.
* Aphakia or amblyopia.
* Have undergone corneal refractive surgery or any anterior segment surgery.
* Abnormal lacrimal secretions.
* Has diabetes.
* Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of chronic eye disease (e.g. glaucoma).
* Pregnant or lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 30 days.

Primary outcomes:
measure: Comfort
timeFrame: Up to 4 weeks
measure: Visual Acuity (VA)
timeFrame: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
measure: Lens Surface Wetting
timeFrame: Up to 4 weeks
measure: Film Deposits
timeFrame: Up to 4 weeks
measure: Corneal Staining
timeFrame: Up to 4 weeks
measure: Limbal Hyperemia
timeFrame: Up to 4 weeks
measure: Bulbar Hyperemia
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Memphis
country: United States
facility: Optometry Group PLLC
state: Tennessee
city: Tyler
country: United States
facility: Frazier Vision, Inc.
state: Texas
city: Reading
country: United Kingdom
facility: Eyesite
state: Berkshire
city: Poole
country: United Kingdom
facility: Leightons and Tempany
state: Bournemouth
city: Chew Magna
country: United Kingdom
facility: Brock and Houlford
state: Bristol
city: Uxbridge
country: United Kingdom
facility: Harrold Opticians
state: Middlesex
city: Eastcote
country: United Kingdom
facility: First Contact
state: Pinner
city: Farnham
country: United Kingdom
facility: Visioncare Research Ltd
state: Surrey
Study officials:
affiliation: Visioncare Research Ltd.
name: Frances L Nicklin, Bsc, MCOptom
role: PRINCIPAL_INVESTIGATOR
References: