A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

NCT03499067 | Completed Results

• 1 other identifier: CV-18-07
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Conditions

Myopia

Outcome Measures

Primary Outcomes (12)

• Lens Surface Wettability

  Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

  Baseline

• Lens Surface Wettability

  Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

  2-weeks

• Lens Surface Wettability

  Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)

  4-weeks

• Lens Surface Deposits

  Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)

  Baseline

• Lens Surface Deposits

  Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface).

  2-weeks

• Lens Surface Deposits

  Lens surface deposits was measured on a Scale 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 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)

  4-weeks

• Overall Lens Fit Acceptance

  Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

  Baseline

• Overall Lens Fit Acceptance

  Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

  2-Weeks

• Overall Lens Fit Acceptance

  Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)

  4-Weeks

• Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration

  Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)

  Baseline

• Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration

  Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)

  2-weeks

• Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration

  Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)

  4-weeks

Secondary Outcomes (6)

• Bulbar Conjunctiva Hyperaemia

  Baseline

• Bulbar Conjunctiva Hyperaemia

  2-weeks

• Bulbar Conjunctiva Hyperaemia

  4-weeks

• Limbal Conjunctiva Hyperaemia

  Baseline

• Limbal Conjunctiva Hyperaemia

  2-weeks

Study Arms (2)

Test lens

EXPERIMENTAL

Subjects wearing the test contact lens either as first or second pair during the cross-over study.

Device: Test lens; Device: Control lens

Control lens

ACTIVE COMPARATOR

Subjects wearing the control contact lens either as first or second pair during the cross-over study.

Device: Test lens; Device: Control lens

Interventions

Test lens DEVICE

Contact lens

Also known as: Invigor I lens

Control lens; Test lens

Control lens DEVICE

Contact lens

Also known as: Clariti lens

Control lens; Test lens

Eligibility Criteria

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

You may qualify if:

• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
• Has no more than 0.75 diopters of refractive astigmatism.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

You may not qualify if:

• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications that will affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.
• Known allergy to a product used in this study (ex. Shellfish allergy)
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

Clinical Research Center, University of California, Berkeley

Berkeley, California, 94704, United States

Location

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a double-masked study in which both participant and investigator will be masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 11, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)