A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Sapphire Lens; Device: enfilcon A

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94704
      • Clinical Research Center, University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will only be eligible for the study if:

  1. Is at least 18 years of age for the USA and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is an adapted soft contact lens wearer;
  5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;
  6. Has no more than 0.75 diopters of refractive astigmatism;
  7. Willing to wear contact lens in both eyes;
  8. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;

  9. 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:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Is aphakic;
  8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sapphire lens; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.	Device: Sapphire Lens; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Active Comparator: enfilcon A; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.	Device: enfilcon A; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Wettability	Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)	4 weeks
Subjective Ratings for Comfort After Lens Insertion	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	Baseline (5 minutes post lens dispensing)
Subjective Ratings for Comfort After Lens Insertion	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	4 weeks
Percentage of Participants With a Lens Preference Based on Subjective Comfort	Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference	Baseline (5 minutes post lens dispensing)
Percentage of Participants With a Lens Preference Based on Subjective Comfort	Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference	4 weeks
Lens Wettability	Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)	Baseline (5 minutes post lens dispensing)
Lens Surface Deposition	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)	Baseline (5 minutes post lens dispensing)
Lens Surface Deposition	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)	4 weeks

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Meng Lin, Clinical Research Center, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-15-46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes