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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Contact Lens Lubrication
Interventions Drug: carboxymethylcellulose based eye drop formula
Drug: carboxymethylcellulose sodium based eye drop solution
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 244 121
Completed 236 114
Not Completed 8 7
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS® Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 244 121 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 121 participants 365 participants
<40 years 170 90 260
≥40 years 74 31 105
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 121 participants 365 participants
Female
182
  74.6%
90
  74.4%
272
  74.5%
Male
62
  25.4%
31
  25.6%
93
  25.5%
1.Primary Outcome
Title Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Hide Description 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.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population included all randomized participants.
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 244 121
Measure Type: Number
Unit of Measure: percentage of participants
Better 11.1 10.7
No Change 88.9 88.4
Worse 0.0 0.8
2.Other Pre-specified Outcome
Title Average Daily Contact Wearing Time
Hide Description The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 236 114
Mean (Standard Deviation)
Unit of Measure: hours per day
13.8  (2.59) 13.9  (3.01)
3.Other Pre-specified Outcome
Title Reason for Contact Lens Replacement
Hide Description 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.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Completed population included all enrolled participants who received study treatment and completed the study through Day 90.
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 236 114
Overall Number of Units Analyzed
Type of Units Analyzed: Contact Lenses Replaced
177 86
Measure Type: Number
Unit of Measure: eyes
Scheduled Replacement 158 74
Discomfort 11 5
Lens Damage 9 7
Unacceptable Vision 1 0
Lens Lost 4 0
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment-emergent adverse events (adverse events which occur after study drug is first administered) are reported.
 
Arm/Group Title Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Affected / at Risk (%) Affected / at Risk (%)
Total   1/244 (0.41%)   0/121 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1 [1]  1/182 (0.55%)  0/90 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
[1]
Not treatment-related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carboxymethylcellulose Based Eye Drop Formula REFRESH CONTACTS®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/244 (0.00%)   0/121 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01844388     History of Changes
Other Study ID Numbers: 10077X-001
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Submitted: September 25, 2014
Results First Posted: September 29, 2014
Last Update Posted: April 16, 2019