NCT03278223

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

Completed NA Results posted Last updated 26 March 2021

What this trial tests

NA trial testing Test solution in Myopia in 194 participants. Completed in 20 December 2017.

Timeline

14 August 2017

Primary endpoint
17 November 2017

20 December 2017

Quick facts

Lead sponsor	OTE North America
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	194
Start date	14 August 2017
Primary completion	17 November 2017
Estimated completion	20 December 2017
Sites	11 locations across United Kingdom, United States

Drugs / interventions tested

• Test solution
• Control solution

Conditions studied

• Myopia — all drugs for Myopia →
• Hyperopia — all drugs for Hyperopia →

Sponsor

OTE North America

Who can join

18 and older, any sex, with Myopia or Hyperopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Comfort Primary · Up to 4 weeks

Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)

Group	Value	95% CI
Test Solution	8.44	± 0.31
Control Solution	8.11	± 0.33

Visual Acuity (VA) Primary · 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.

Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of

Group	Value	95% CI
Test Solution	-0.02	± 0.01
Control Solution	-0.02	± 0.01

Lens Surface Wetting Primary · Up to 4 weeks

Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)

Group	Value	95% CI
Test Solution	3.33	± 0.17
Control Solution	3.28	± 0.17

Film Deposits Primary · Up to 4 weeks

Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)

Group	Value	95% CI
Test Solution	0.37	± 0.12
Control Solution	0.57	± 0.13

Corneal Staining Primary · Up to 4 weeks

Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.

Group	Value	95% CI
Test Solution	0.10	± 0.04
Control Solution	0.27	± 0.05

Limbal Hyperemia Primary · Up to 4 weeks

Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)

Group	Value	95% CI
Test Solution	0.43	± 0.12
Control Solution	0.44	± 0.12

Bulbar Hyperemia Primary · Up to 4 weeks

Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)

Group	Value	95% CI
Test Solution	0.55	± 0.14
Control Solution	0.55	± 0.14

Adverse events — posted to ClinicalTrials.gov

Time frame: Subjects participated in the study for a total duration of 30±4 days. Adverse Event data was collected over a period of approximately 12 weeks from the first participant receiving study product.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Solution

Serious: 0/125 (0%)

Deaths: 0/125

Control Solution

Serious: 0/69 (0%)

Deaths: 0/69

Other adverse events (9 terms — click to expand)

Reaction	System	Test Solution	Control Solution
Solution induced Corneal staining	Eye disorders	—	—
Anxiety	General disorders	—	—
Ocular Burning	Eye disorders	—	—
Viral Stomach Bug	Gastrointestinal disorders	—	—
Solution reaction	Eye disorders	—	—
Solution reaction	Eye disorders	—	—
Left eye sore and painful	Eye disorders	—	—
Symptoms requiring action, (a piece of contact lens (foreign body) removed	Eye disorders	—	—
Possible reaction to material or solution.	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03278223 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.