A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Lens Surface Deposition
Study Overview
Brief Summary
This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.
The study results were not used for design validation of test lens.
Detailed Description
Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.
The study results were not used for design validation of test lens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects will only be eligible for the study if:
- •Is at least 18 years of age for the USA and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is an adapted soft contact lens wearer;
- •Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;
- •Has no more than 0.75 diopters of refractive astigmatism;
- •Willing to wear contact lens in both eyes;
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
- •To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.
Exclusion Criteria
- •Subjects will not be eligible to take part in the study if:
- •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 refractive error 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.
Arms & Interventions
Sapphire lens
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Intervention: Sapphire Lens (Device)
enfilcon A
Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Intervention: enfilcon A (Device)
Outcomes
Primary Outcomes
Lens Surface Deposition
Time Frame: 4 weeks
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Subjective Ratings for Comfort After Lens Insertion
Time Frame: 4 weeks
Subjective ratings for comfort on a 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
Lens Wettability
Time Frame: 4 weeks
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Time Frame: 4 weeks
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Subjective Ratings for Comfort After Lens Insertion
Time Frame: Baseline (5 minutes post lens dispensing)
Subjective ratings for comfort on a 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
Percentage of Participants With a Lens Preference Based on Subjective Comfort
Time Frame: Baseline (5 minutes post lens dispensing)
Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Lens Wettability
Time Frame: Baseline (5 minutes post lens dispensing)
Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Lens Surface Deposition
Time Frame: Baseline (5 minutes post lens dispensing)
Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (\<0.1mm), 2- \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Secondary Outcomes
No secondary outcomes reported