Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: enfilcon A; Device: senofilcon A

• Registration Number: NCT02356692
• Lead Sponsor: Coopervision, Inc.

Brief Summary

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Detailed Description

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Status Verified: 2020-10
• Results First Submitted: 2020-10-05
• Results First Submitted QC: 2020-10-30
• Last Update Submitted: 2020-10-30
• Results First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Based on his/her knowledge, must be in good general health.

2. Be 18 to 38 years old.

3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.

4. Read, indicate understanding of, and sign Written Informed Consent.

5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.

6. Require a visual correction in both eyes.

7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.

8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.

9. 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).
   • 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.

Exclusion Criteria

1. 0.75D or greater of refractive astigmatism in either eye.

2. Presbyopic or current monovision contact lens wear.

3. Cannot be currently wearing either lenses (Avaira or Oasys).

4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.

5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.

6. 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)

7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.

8. Aphakia, Keratoconus or a highly irregular cornea.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enfilcon A	enfilcon A	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.
enfilcon A	senofilcon A	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.
senofilcon A	enfilcon A	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.
senofilcon A	senofilcon A	participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Primary Outcome Measures

Name	Time	Method
Comfort at Insertion	15 minutes	Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Comfort Preference	15 minutes	Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.

Trial Locations

Locations (3)

Schaeffer Eye Associates; 🇺🇸 Birmingham, Alabama, United States

Beaches Family Eyecare; 🇺🇸 Jacksonville, Florida, United States

Todays Eyecare, LLC; 🇺🇸 Lafayette, Louisiana, United States