Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01614600
First received: June 6, 2012
Last updated: November 8, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 6, 2012 | ||||
| Last Updated Date | November 8, 2012 | ||||
| Start Date ICMJE | June 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean change from baseline in contact lens-related dryness symptoms at 30 days [ Time Frame: Baseline, 30 days ] [ Designated as safety issue: No ] Contact lens symptoms will be measured using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects will rate their frequency and severity of eight common contact lens-related symptoms to compile an average aggregate score. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01614600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers | ||||
| Official Title ICMJE | Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers | ||||
| Brief Summary | The purpose of this study is to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers are switched to DAILIES AquaComfort Plus lenses for a two-week period using composite scores on the Contact Lens Dry Eye (CLDE) Questionnaire. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®)
Commercially marketed hydrogel contact lens for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus® |
||||
| Study Arm (s) | Experimental: DACP
Contact lenses per participant's habitual prescription worn bilaterally on a daily wear, daily disposable basis for 30 days.
Intervention: Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®) |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 88 | ||||
| Completion Date | September 2012 | ||||
| Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01614600 | ||||
| Other Study ID Numbers ICMJE | A00849 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alcon Research | ||||
| Study Sponsor ICMJE | Alcon Research | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Alcon Research | ||||
| Verification Date | November 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||