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A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

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: NCT02553772
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
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 Dry Eye Syndromes
Interventions Drug: Carboxymethylcellulose Based Eye Drop
Drug: Carboxymethylcellulose Sodium 0.5%
Enrollment 242
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Period Title: Overall Study
Started 120 122
Completed 114 116
Not Completed 6 6
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             2             1
Withdrawal of Consent             1             1
Lack of Efficacy             1             0
Other Miscellaneous Reasons             0             1
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED Total
Hide Arm/Group Description Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Total of all reporting groups
Overall Number of Baseline Participants 120 122 242
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 122 participants 242 participants
54.3  (17.3) 52.8  (16.7) 53.5  (17.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 122 participants 242 participants
< 30 years 16 14 30
30 to 40 years 11 18 29
> 40 years 93 90 183
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 122 participants 242 participants
Female
84
  70.0%
95
  77.9%
179
  74.0%
Male
36
  30.0%
27
  22.1%
63
  26.0%
1.Primary Outcome
Title Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Hide Description The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants.
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description:
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Overall Number of Participants Analyzed 120 122
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 41.12  (12.68) 39.63  (11.33)
Change at Day 90 -15.61  (16.52) -13.16  (17.71)
2.Secondary Outcome
Title Change From Baseline in Tear Break-up Time (TBUT)
Hide Description TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description:
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Overall Number of Participants Analyzed 120 122
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline Number Analyzed 120 participants 122 participants
4.77  (1.68) 4.93  (1.74)
Change at Day 90 Number Analyzed 115 participants 118 participants
1.12  (1.93) 1.34  (2.62)
3.Secondary Outcome
Title Change From Baseline in Corneal Staining Score
Hide Description Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description:
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Overall Number of Participants Analyzed 120 122
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 120 participants 122 participants
4.49  (3.39) 4.51  (3.29)
Change at Day 90 Number Analyzed 115 participants 119 participants
-1.49  (2.37) -0.58  (2.70)
4.Secondary Outcome
Title Change From Baseline in Conjunctival Staining Score
Hide Description Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description:
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Overall Number of Participants Analyzed 120 122
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 120 participants 122 participants
6.73  (5.65) 5.87  (4.46)
Change at Day 90 Number Analyzed 115 participants 119 participants
-1.76  (4.42) -1.18  (4.03)
5.Secondary Outcome
Title Change From Baseline in the Schirmer Test
Hide Description The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).
Time Frame Baseline, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. "n" is the number of participants in the category with data available at the given time-point.
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description:
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Overall Number of Participants Analyzed 120 122
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Number Analyzed 120 participants 122 participants
9.91  (7.10) 9.85  (6.82)
Change at Day 90 Number Analyzed 115 participants 118 participants
1.40  (7.13) 1.38  (7.21)
Time Frame 120 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OM3 Tear REFRESH OPTIVE® ADVANCED
Hide Arm/Group Description Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
All-Cause Mortality
OM3 Tear REFRESH OPTIVE® ADVANCED
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OM3 Tear REFRESH OPTIVE® ADVANCED
Affected / at Risk (%) Affected / at Risk (%)
Total   1/120 (0.83%)   1/122 (0.82%) 
Gastrointestinal disorders     
Colitis ischaemic  1  1/120 (0.83%)  0/122 (0.00%) 
Diverticulum  1  1/120 (0.83%)  0/122 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  0/120 (0.00%)  1/122 (0.82%) 
Fall  1  0/120 (0.00%)  1/122 (0.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OM3 Tear REFRESH OPTIVE® ADVANCED
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/122 (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
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 1-877-277-8566
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02553772     History of Changes
Other Study ID Numbers: 11182X-001
First Submitted: September 16, 2015
First Posted: September 18, 2015
Results First Submitted: August 16, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017