Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01684046
First received: September 10, 2012
Last updated: March 19, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare clinical and comfort outcomes of two marketed multi-purpose contact lens solutions.
| Condition | Intervention |
|---|---|
|
Myopia Contact Lens Comfort |
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2 |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Subjective lens wear comfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 196 |
| Study Start Date: | November 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Opti-Free, then RevitaLens
Opti-Free PureMoist Multi-Purpose Disinfecting solution used first, followed by RevitaLens OcuTec Multi-Purpose Disinfecting Solution. Each product used 30 days for contact lens care as specified in protocol, with a 2-day washout prior to each 30-day period.
|
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: OPTI-FREE® PureMoist™
Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: RevitaLens OcuTec®
|
|
RevitaLens, then Opti-Free
RevitaLens Ocutec Multi-Purpose Disinfecting Solution, followed by Opti-Free PureMoist Multi-Purpose Disinfecting Solution. Each product used 30 days for contact lens care as specified in protocol, with a 2-day washout prior to each 30-day period.
|
Device: Opti-Free PureMoist Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: OPTI-FREE® PureMoist™
Device: RevitaLens OcuTec Multi-Purpose Disinfecting Solution
Commercially available (US and Europe) contact lens care solution used as specified in protocol for 30 days.
Other Name: RevitaLens OcuTec®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1;
- Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study;
- Must have habitually used a Biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1;
- Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
- Have access, capability and willingness to review and answer text messages;
- Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
- Willing to follow the study procedures and visit schedule;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Need to wear lenses on an extended wear (i.e overnight) basis during the study;
- Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), Alexidine or ALDOX preserved lens care products;
- Monocular (only one eye with functional vision) or fit with only one lens;
- Wearing toric or multifocal contact lenses or fit with monovision;
- Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
- Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
- Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
- Ocular surgery within the 12 months prior to Visit 1;
- Participation in any other clinical trial within 30 days of enrollment;
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684046
Locations
| United States, Texas | |
| Contact Alcon Call Center at 1-888-451-3937 for Trial Locations | |
| 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: | NCT01684046 History of Changes |
| Other Study ID Numbers: | M-12-041 |
| Study First Received: | September 10, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board United Kingdom: Research Ethics Committee Germany: Ethics Commission |
Keywords provided by Alcon Research:
|
multi-purpose solution silicone hydrogel contact lenses |
comfort Opti-Free RevitaLens |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013