Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

NCT03098745 | Completed Results

• 1 other identifier: EX-MKTG-79
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (11)

• Visual Acuity

  High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.

  Baseline (lens insertion), 1 hour

• Comfort

  Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)

  Insertion, 1hr

• Lens Centration

  Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)

  Insertion

• Lens Centration

  Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)

  1 Hour

• Post-blink Lens Movement

  Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)

  Insertion

• Post-blink Lens Movement

  Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)

  1 Hour

• Lens Fit Acceptance

  Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)

  Insertion

• Lens Fit Acceptance

  Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)

  1 Hour

• Lens Fit Preference

  Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))

  1 Hour

• Limbal Redness

  Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)

  1 Hour

• Bulbar Redness

  Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)

  1 Hour

Study Arms (3)

Omafilcon A

ACTIVE COMPARATOR

Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.

Device: Omafilcon A

Somofilcon A

ACTIVE COMPARATOR

Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.

Device: Somofilcon A

Omafilcon A - Proclear (PC)

ACTIVE COMPARATOR

Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.

Device: Omafilcon A - Proclear (PC)

Interventions

Omafilcon A DEVICE

contact lens

Omafilcon A

Somofilcon A DEVICE

contact lens

Somofilcon A

Omafilcon A - Proclear (PC) DEVICE

contact lens

Omafilcon A - Proclear (PC)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 40 years of age (inclusive).
• Has had a self-reported visual exam in the last two years.
• Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease.
• Has read, understood and signed the information consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule.
• Is willing to comply with the visit schedule.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to - 6.00D
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• Presence of clinically significant (grade 2-4) anterior segment abnormalities.
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• Pterygium, pinguecula, or corneal scars within the visual axis
• Neovascularization \> 0.75 mm in from of the limbus
• Giant papillary conjunctivitis (GCP) worse than grade 1
• Anterior uveitis or iritis (past or present)

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Optometry Clinic, National Autonomous University

Mexico City, Mexico

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr.Jose A.Vega O.D., MSc., FAAO
• Organization: CooperVision Inc.

javega@coopervision.com

9256213761

Study Officials

• Ruben Velázquez Guerrero, MSc., FIACLE

  National Autonomous University, School of Optometry

  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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: February 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: April 11, 2017
• Last Updated: April 9, 2019
• Results First Posted: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)