Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00929487
First received: June 25, 2009
Last updated: September 6, 2012
Last verified: September 2012
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Purpose
The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: Contact lens multi-purpose solution Other: Saline/blister pack solution Device: Contact lenses |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Corneal Staining [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Subjective Comfort [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
| Enrollment: | 278 |
| Study Start Date: | May 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Contact lens solution #1 |
Device: Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
Device: Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
|
| Experimental: Contact lens solution #2 |
Device: Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
Device: Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
|
| Experimental: Contact lens solution #3 |
Device: Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
Device: Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
|
| Experimental: Contact lens solution #4 |
Device: Contact lens multi-purpose solution
Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
Other Names:
Device: Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
|
| Active Comparator: Saline/blister pack solution |
Other: Saline/blister pack solution
A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
Other Names:
Device: Contact lenses
CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.
Other Names:
|
Detailed Description:
This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have read, understood, signed, and dated the written Informed Consent.
- Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
- Vision correctable to at least 20/30 Snellen.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Topical ocular medication use.
- History of hypersensitivity to any component of the study contact lens care systems.
- Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
- Pregnant, lactating, or planning a pregnancy.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00929487 History of Changes |
| Other Study ID Numbers: | SMA-09-14/RDG-11-152 |
| Study First Received: | June 25, 2009 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee France: Institutional Ethical Committee Philippines: Ethics Committee |
Keywords provided by Alcon Research:
|
contact lens wear contact lens solution corneal staining |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases Contact Lens Solutions |
Disinfectants Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013