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

NCT02518490 | Completed Results FDA Device

• 1 other identifier: CV-15-46
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (8)

• 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 Wettability

  Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

  4 weeks

• 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

Study Arms (2)

Sapphire lens

EXPERIMENTAL

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Device: Sapphire Lens

enfilcon A

ACTIVE COMPARATOR

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Device: enfilcon A

Interventions

Sapphire Lens DEVICE

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Sapphire lens

enfilcon A DEVICE

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

enfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen
• Organization: CooperVision, Inc.

mnguyen@coopervision.com

925-730-6716

Study Officials

• Meng Lin

  Clinical Research Center, University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Locations

US (1)