A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

Myopia Clinical Trial

Official title:

A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500368
• Other study ID #: CV-15-36
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Description:

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion criteria:

-A person is eligible for inclusion in the study if he/she:

• Is at least 17 years of age and has full legal capacity to volunteer

• Has read and understood the information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses

• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

-A person will be excluded from the study if he/she:

• Is participating in any concurrent clinical or research study

• Has any known active* ocular disease and/or infection

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable**

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

• Is aphakic

• Has undergone corneal refractive surgery.

For the purposes of this study, active* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• silicone hydrogel lens (test)
contact lens
• enfilcon A lens (control)
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week
Primary	Dryness	Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week
Secondary	Lens Wettability	Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.	Baseline and 1 week
Secondary	Surface Appearance	Grade ratings category (smooth, grainy, or other)	Baseline
Secondary	Surface Appearance	Grade ratings category (smooth, grainy, or other)	1 week
Secondary	High Contrast Acuity at High Room Illumination	Logarithm of the Minimum Angle or Resolution (LogMAR) Chart	Baseline and 1 week
Secondary	Lens Deposition	Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced	Baseline and 1 week
Secondary	Lens Problems	Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.	Baseline and 1 week
Secondary	Lens Centration	Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.; (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior	Baseline
Secondary	Lens Centration	Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.; (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior	1 week
Secondary	Post-blink Movement	Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)	Baseline and 1 week
Secondary	Lens Tightness	Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.	Baseline and 1 week
Secondary	Visual Quality	Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week
Secondary	Ease of Lens Insertion	Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye	Baseline and 1 week
Secondary	Ease of Lens Removal	Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.	1 week
Secondary	Overall Lens Fit	Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all); Poor (lens could be worn with supervision only); Fair (would prefer to refit, but clinically acceptable); Good (fit could be slightly improved); Very good (optimal)	Baseline and 1 week
Secondary	Bulbar Hyperemia	Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.	Baseline and 1 week
Secondary	Limbal Hyperemia	Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.	Baseline and 1 week
Secondary	Corneal Dehydration Staining	Corneal Staining: Dehydration Staining: Yes/No	1 week
Secondary	Corneal Staining (Extent)	Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior	Baseline and 1 week
Secondary	Conjunctival Indentation	Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	Baseline and 1 week.
Secondary	Conjunctival Staining	Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent	Baseline and 1 week