Comparative Study of Two Marketed Spherical Soft Contact Lenses

NCT01582789 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-37
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (6)

• Comfort - First Intervention

  Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,

  Baseline

• Comfort - Second Intervention

  Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,

  Baseline

• Comfort - First Intervention

  Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).

  2 Weeks

• Comfort - Second Intervention

  Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).

  2 Weeks

• Comfortable Wearing Time - First Intervention

  Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.

  2 Weeks

• Comfortable Wearing Time - Second Intervention

  Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.

  2 Weeks

Study Arms (2)

enfilcon A/senofilcon A

ACTIVE COMPARATOR

Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks.

Device: enfilcon A; Device: senofilcon A

senofilcon A/enfilcon A

ACTIVE COMPARATOR

Subjects were randomized to wear senofilcon A then enfilcon A for two weeks

Device: enfilcon A; Device: senofilcon A

Interventions

enfilcon A DEVICE

enfilcon A daily wear soft contact lens

enfilcon A/senofilcon A; senofilcon A/enfilcon A

senofilcon A DEVICE

senofilcon A daily wear soft contact lens

enfilcon A/senofilcon A; senofilcon A/enfilcon A

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Based on his/her knowledge, must be in good general health.
• Be 18 to 38 years old.
• Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
• Read, indicate understanding of, and sign Written Informed Consent.
• Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
• Require a visual correction in both eyes.
• Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
• Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
• Must be able to wear their lenses at least 10 working days over the next 2-weeks; \> 8 hours/day assuming there are no contraindications for doing so.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia

You may not qualify if:

• Greater than 0.50D of refractive astigmatism in either eye.
• Presbyopic or current monovision contact lens wear.
• Cannot be currently wearing of either lenses (Avaira or Oasys)
• Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• Presence of ocular or systemic disease or need of medication 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 the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
• Aphakia, Keratoconus or a highly irregular cornea

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

Advanced Eyecare

Pismo Beach, California, 93449, United States

Location

Eric M. White, OD, Inc.

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Don Siegel, OD
• Organization: CooperVision, US

dsiegel@coopervision.com

623-544-3877

Study Officials

• Don Siegel, OD

  CooperVision, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 23, 2012
• Study Start: April 9, 2012
• Primary Completion: May 1, 2012
• Study Completion: July 31, 2012
• Last Updated: October 27, 2020
• Results First Posted: May 4, 2016

Record last verified: 2020-10

Locations

US (2)