Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
This study is not yet open for participant recruitment.
Verified April 2013 by Alcon Research
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01809197
First received: March 8, 2013
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to compare comfort between two systems of contact lens+contact lens care.
| Condition | Intervention |
|---|---|
|
Refractive Error Myopia Hyperopia Astigmatism Presbyopia |
Device: Lotrafilcon B contact lenses Device: Senofilcon A contact lenses Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) Device: Habitual Multi-Purpose Solution (MPS) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Likert Item: "I can comfortably wear my lenses" [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 384 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lotrafilcon B/OPTI-FREE
Lotrafilcon B contact lenses worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
|
Device: Lotrafilcon B contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Other Names:
Device: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
Other Name: OPTI-FREE® PureMoist™
|
|
Active Comparator: Senofilcon A/Habitual MPS
Senofilcon A contact lenses worn on a daily wear basis for 30 days, with habitual MPS lens care system
|
Device: Senofilcon A contact lenses
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
Other Names:
Device: Habitual Multi-Purpose Solution (MPS)
Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
|
Detailed Description:
Prior to the 30-day study period, participants will be fitted with study lenses in a masked manner and undergo a run-in period of 4-8 days to adjust to the randomized lenses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Sign informed consent.
- Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
- Willing to wear contact lenses on a daily wear basis for the duration of the study.
- Currently using a multi-purpose solution, as specified in protocol.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.
- Willing to follow the study procedures and visit schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Currently wearing any Air Optix or Acuvue brand of silicone hydrogel contact lenses.
- Currently using any Opti-Free brand of multi-purpose solution.
- Must wear contact lenses on an extended wear (overnight) basis during the study.
- Known sensitivity or intolerance to POLYQUAD or ALDOX preserved lens care products.
- Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
- Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.
- Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.
- Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
- Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.
- Ocular surgery within the 12 months prior to Visit 1.
- Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
- Participation in any clinical study within 30 days of Visit 1.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809197
Contacts
| Contact: Alcon Call Center | 1-888-451-3937 | alcon.medinfo@alcon.com |
Locations
| United States, Texas | |
| Contact Alcon Call Center for Trial Locations | Not yet recruiting |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Jessie Lemp, MS | Alcon Research |
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01809197 History of Changes |
| Other Study ID Numbers: | M-12-056 |
| Study First Received: | March 8, 2013 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Refractive error Myopia Hyperopia Astigmatism |
Presbyopia Contact lenses Contact lens solution Comfort |
Additional relevant MeSH terms:
|
Presbyopia Astigmatism Hyperopia Myopia Refractive Errors Eye Diseases |
Contact Lens Solutions Disinfectants Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013