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A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01844388
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : September 29, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Results First Submitted Date  ICMJE September 25, 2014
Results First Posted Date  ICMJE September 29, 2014
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE May 29, 2013
Actual Primary Completion Date December 2, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline [ Time Frame: Baseline, Day 90 ]
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
Contact Lens Distance Visual Acuity [ Time Frame: 90 Days ]
Change History Complete list of historical versions of study NCT01844388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2014)
  • Average Daily Contact Wearing Time [ Time Frame: Day 90 ]
    The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.
  • Reason for Contact Lens Replacement [ Time Frame: Day 90 ]
    The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Official Title  ICMJE Not Provided
Brief Summary This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Contact Lens Lubrication
Intervention  ICMJE
  • Drug: carboxymethylcellulose based eye drop formula
    1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
  • Drug: carboxymethylcellulose sodium based eye drop solution
    1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
    Other Name: REFRESH CONTACTS®
Study Arms  ICMJE
  • Experimental: Carboxymethylcellulose Based Eye Drop Formula
    1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
    Intervention: Drug: carboxymethylcellulose based eye drop formula
  • Active Comparator: REFRESH CONTACTS®
    1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
    Intervention: Drug: carboxymethylcellulose sodium based eye drop solution
Publications * Nichols JJ, Lievens CW, Bloomenstein MR, Liu H, Simmons P, Vehige J. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy. Optom Vis Sci. 2016 Aug;93(8):979-86. doi: 10.1097/OPX.0000000000000878.

*   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
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
365
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2013)
360
Actual Study Completion Date  ICMJE December 2, 2013
Actual Primary Completion Date December 2, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

Exclusion Criteria:

  • Wearing monovision lenses
  • Have had refractive surgery within the previous 12 months
  • Have infection of the eye, eyelids or eye structures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844388
Other Study ID Numbers  ICMJE 10077X-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP