N/A Completed N=194 Randomized Double-blind Other

One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System

Myopia · Hyperopia

Source: ClinicalTrials.gov NCT03278223 ↗

Enrolled (actual)

194

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcomePrimary: Comfort — 8.44; 8.11 score on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comfort	8.44; 8.11	—
PRIMARY Visual Acuity (VA)	-0.02; -0.02	—
PRIMARY Lens Surface Wetting	3.33; 3.28	—
PRIMARY Film Deposits	0.37; 0.57	—
PRIMARY Corneal Staining	0.10; 0.27	—
PRIMARY Limbal Hyperemia	0.43; 0.44	—
PRIMARY Bulbar Hyperemia	0.55; 0.55	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03278223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.