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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Sapphire Lens; Device: enfilcon A

• Registration Number: NCT02518490
• Lead Sponsor: Coopervision, Inc.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Results First Submitted: 2020-08-27
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Results First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sapphire lens	Sapphire Lens	Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
enfilcon A	enfilcon A	Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Primary Outcome Measures

Name	Time	Method
Lens Surface Deposition	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	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	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	4 weeks	Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference

Trial Locations

Locations (1)

Clinical Research Center, University of California, Berkeley; 🇺🇸 Berkeley, California, United States