An Investigation of the Impact of Localized Topical Anest... | NCT03733899

NCT03733899

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upper lid margin/Lower lid margin/Cornea	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences of an ocular surface region. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).	Diagnostic Test: Local Anesthesia Diagnostic Test: Placebo
Lower lid margin/Cornea/ Upper lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).	Diagnostic Test: Local Anesthesia Diagnostic Test: Placebo
Cornea/Upper lid margin/Lower lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).	Diagnostic Test: Local Anesthesia Diagnostic Test: Placebo
Cornea/Lower lid margin/Upper lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local Anesthesia	Diagnostic Test	Minims Proxymetacaine hydrochloride Eye Drops	Cornea/Lower lid margin/Upper lid margin Cornea/Upper lid margin/Lower lid margin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Comfort Scores	Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.	5 and 10 Minutes post-treament
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment	Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.	14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic	Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.	Immediately after lens-insertion, 5 and 10 minutes post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic	Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.	5 and 10 minutes post treatment
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. They are of legal age (18 years) and capacity of volunteer.
2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
3. They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
5. They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.
6. They are willing to wear their lenses for approximately 14 hours on study days.
7. They have a wearable pair of spectacles, if applicable.
8. They agree not to participate in other clinical research for the duration of this study.
9. They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.
  
  Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1. They have an ocular disorder, which would normally contra-indicate contact lens wear.
2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They have had cataract or corneal refractive surgery.
5. They are pregnant or breast-feeding by self-report.
6. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
7. They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
8. They have a history of severe allergic reaction or anaphylaxis.
9. They have a history of cardiac disease or hyperthyroidism.
10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
11. They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
12. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
13. They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

Facility	Status	City	State	ZIP	Country	Contacts
The University of Manchester		Manchester		M13 9PL	United Kingdom

Arm/Group Information

ID	Title	Description
FG000	Lower Lid Margin/Upper Lid Margin/Cornea	Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the upper lid margin during period 2 and the cornea at period 3.
FG001	Lower Lid Margin/Cornea/Upper Lid Margin	Subjects assigned to recieved two treatmens contralaterally, in the lower lid margin during period 1, the cornea during period 2 and the upper lid margin during period 3.
FG002	Upper Lid Margin/Lower Lid Margin/Cornea	Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the lower lid margin during period 2 and the cornea during period 3.
FG003	Upper Lid Margin/Cornea/Lower Lid Margin	Subjects assigned to recieved two treatmens contralaterally, in the upper lid margin during period 1, the cornea during period 2 and the lower lid margin during period 3.
FG004	Cornea/Lower Lid Margin/Upper Lid Margin	Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the lower lid margin during period 2 and the upper lid maring during period 3.
FG005	Cornea/Upper Lid Margin/Lower Lid Margin	Subjects assigned to recieved two treatmens contralaterally, in the Cornea during period 1, the upper lid margin during period 2 and the lower lid maring during period 3.

ID	Title	Description
BG000	All Dispensed Subjects	All subjects dispensed at least one study lens.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Subjective Comfort Scores

Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.

All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.

Posted

Mean

Standard Deviation

Units on a Scale

5 and 10 Minutes post-treament

eyes

ID	Title	Description
OG000	Test (Anesthetic)- Cornea	Eyes that instilled the Test (Anesthetic) in either the right or left corneal ocular region.
OG001	Placebo- Cornea	Eyes that instilled the Placebo in either the right or left corneal ocular region.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	subjects that were exposed to the placebo during any point in the study.