Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

NCT04886479 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-89
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

Brief Summary

This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

• Limbal Redness - DDSH, DDH, Non-lens Groups

  Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).

  6-8 hours of habitual wear

• Bulbar Redness DDSH, DDH, Non-lens Groups

  Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).

  6-8 hours of habitual wear

• Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups

  Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.

  6-8 hours of habitual wear

• Limbal Redness - DDSH, DDH Groups

  Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.

  Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal

• Bulbar Redness - DDSH, DDH Groups

  Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.

  Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal

Secondary Outcomes (1)

• Central Corneal Swelling (%) - DDSH, DDH Groups

  Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal

Study Arms (3)

Daily Disposable Silicone Hydrogel Contact Lens Wearers

EXPERIMENTAL

Participants wore Test Lens for 3 hours

Device: Test Lens

Daily Disposable Hydrogel Contact Lens Wearers

EXPERIMENTAL

Participants wore Test Lens for 3 hours

Device: Test Lens

Non-lens Wearers

ACTIVE COMPARATOR

Participants did not receive Test Lens

Other: Control

Interventions

Control OTHER

No lens

Non-lens Wearers

Test Lens DEVICE

Low Dk HEMA contact lens worn for 3 hours

Daily Disposable Hydrogel Contact Lens Wearers; Daily Disposable Silicone Hydrogel Contact Lens Wearers

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years.
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.
• Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 \& 2). This criterion is non-applicable to participants in group 3.
• Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.
• GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.
• GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.
• For groups 1 \& 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group 3.
• Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group 3.
• Has clear and healthy corneas and anterior eye and no active ocular disease;
• Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.
• Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group 3.
• Has a wearable pair of spectacles.

You may not qualify if:

• Is participating in any concurrent clinical trial;
• Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner
• Has any known active ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
• Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study;
• Appears to have any active ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
• Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types;
• Is aphakic;
• Has undergone refractive error surgery, or has a history of any ocular surgery or injury.
• Is a toric or multifocal contact lens wearer.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

CORE, University of Waterloo

Waterloo, Canada

Location

Eurolens Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director Global Clinical Affairs
• Organization: CooperVision Inc.

jvega2@coopervision.com

+19256213761

Study Officials

• Lyndon Jones, PhD FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: March 6, 2019
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2023-11

Locations

GB (1); CA (1)