Comparative Study of Two Marketed Spherical Soft Contact Lenses
This study is ongoing, but not recruiting participants.
Sponsor:
Coopervision, Inc.
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01582789
First received: April 12, 2012
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractive Error |
Device: enfilcon A Device: senofilcon A |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Comparative Study of Two Marketed Spherical Soft Contact Lenses |
Resource links provided by NLM:
Further study details as provided by Coopervision, Inc.:
Primary Outcome Measures:
- Comfort and Dryness [ Time Frame: Initial/Dispensing ] [ Designated as safety issue: No ]Comfort - Ratings of comfort where 0=cannot tolerate and 10=cannot be felt; Dryness - Rating of dryness where 0=feels very dry and 10=did not notice any dryness
- Comfort and Dryness [ Time Frame: 2-week crossover ] [ Designated as safety issue: No ]Comfort - Ratings of comfort where 0=cannot tolerate and 10=cannot be felt; Dryness - Rating of dryness where 0=feels very dry and 10=did not notice any dryness
- Comfort and Dryness [ Time Frame: 4-week visit ] [ Designated as safety issue: No ]Comfort - Ratings of comfort where 0=cannot tolerate and 10=cannot be felt; Dryness - Rating of dryness where 0=feels very dry and 10=did not notice any dryness
Secondary Outcome Measures:
- Vision and Handling [ Time Frame: Initial/Dispensing ] [ Designated as safety issue: No ]Vision - Ratings of vision where 0=Poor and 10=Excellent; Handling - Ratings of handling where 0=Difficult and 10=Easy
- Vision and Handling [ Time Frame: 2-week crossover ] [ Designated as safety issue: No ]Vision - Ratings of vision where 0=Poor and 10=Excellent; Handling - Ratings of handling where 0=Difficult and 10=Easy
- Vision and Handling [ Time Frame: 4-week visit ] [ Designated as safety issue: No ]Vision - Ratings of vision where 0=Poor and 10=Excellent; Handling - Ratings of handling where 0=Difficult and 10=Easy
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: enfilcon A/senofilcon A
enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd
|
Device: enfilcon A
enfilcon A daily wear soft contact lens
Other Names:
Device: senofilcon A
senofilcon A daily wear soft contact lens
Other Names:
|
|
Active Comparator: senofilcon A/enfilcon A
senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd
|
Device: enfilcon A
enfilcon A daily wear soft contact lens
Other Names:
Device: senofilcon A
senofilcon A daily wear soft contact lens
Other Names:
|
Detailed Description:
The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Subjects must satisfy the following conditions prior to inclusion in the study:
- 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
Exclusion Criteria:
Any of the following will render a subject ineligible for inclusion:
- 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
To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582789
Locations
| United States, California | |
| Advanced Eyecare | |
| Pismo Beach, California, United States, 93449 | |
| Eric M. White, OD, Inc. | |
| San Diego, California, United States, 92123 | |
Sponsors and Collaborators
Coopervision, Inc.
Investigators
| Study Director: | Don Siegel, OD | Coopervision, Inc. |
More Information
No publications provided
| Responsible Party: | Coopervision, Inc. |
| ClinicalTrials.gov Identifier: | NCT01582789 History of Changes |
| Other Study ID Numbers: | EX-MKTG-37 |
| Study First Received: | April 12, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013