Target Contact Lens Solution Vs Renu
Brief Summary:
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Symptomatic Contact Lens Wearers | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) Device: renu fresh Multi-Purpose Solution (MPS) Device: Contact lenses | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 591 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine 
| Arm | Intervention/treatment |
|---|---|
| Experimental: Alcon MPDS MPDS used for 30 days as specified in protocol for contact lens care. | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days. Device: Contact lenses Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis. |
| Active Comparator: renu fresh MPS MPS used for 30 days as indicated for contact lens care. | Device: renu fresh Multi-Purpose Solution (MPS) Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days. Other Name: renu® fresh™ Multi-Purpose Solution Device: Contact lenses Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis. |
Primary Outcome Measures :
- Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. [ Time Frame: Day 30 ]
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Secondary Outcome Measures :
- Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. [ Time Frame: Day 30 ]
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
- Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. [ Time Frame: Day 30 ]
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
- Vision correctable to 20/30 or better with contact lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Sensitivity to multi-purpose solutions.
- Use of any topical ocular OTC or prescribed topical ocular medications.
- History (6 months) or current ocular infections or ocular inflammatory events.
- Ocular surgery within the past year.
- Medical condition or use of medications that cause ocular side effects.
- Participation in any investigational study within the past 30 days.
- Other protocol-defined exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187355
Locations
| United States, Texas | |
| Contact Alcon Call Center for Trial Locations | |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01187355 |
| Other Study ID Numbers: | C-09-074 |
| First Posted: | August 24, 2010 Key Record Dates |
| Results First Posted: | July 30, 2012 |
| Last Update Posted: | July 30, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Alcon Research:
| Symptomatic, Contact lens care Multi-purpose solution |
Additional relevant MeSH terms:
| Pharmaceutical Solutions |
Target Contact Lens Solution Vs Renu
Source: https://clinicaltrials.gov/ct2/show/NCT01187355
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