Trial Outcomes & Findings for A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease. (NCT NCT02553772)
NCT ID: NCT02553772
Last Updated: 2017-11-17
Results Overview
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.
COMPLETED
PHASE3
242 participants
Baseline, Day 90
2017-11-17
Participant Flow
Participant milestones
| Measure |
OM3 Tear
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.
|
REFRESH OPTIVE® ADVANCED
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 Study
STARTED
|
120
|
122
|
|
Overall Study
COMPLETED
|
114
|
116
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
OM3 Tear
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.
|
REFRESH OPTIVE® ADVANCED
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 Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal of Consent
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Other Miscellaneous Reasons
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Baseline characteristics by cohort
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
Age, Customized
< 30 years
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
30 to 40 years
|
11 participants
n=5 Participants
|
18 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Age, Customized
> 40 years
|
93 participants
n=5 Participants
|
90 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-treat population included all randomized participants.
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.
Outcome measures
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Baseline
|
41.12 score on a scale
Standard Deviation 12.68
|
39.63 score on a scale
Standard Deviation 11.33
|
|
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Change at Day 90
|
-15.61 score on a scale
Standard Deviation 16.52
|
-13.16 score on a scale
Standard Deviation 17.71
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
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.
Outcome measures
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT)
Change at Day 90
|
1.12 seconds
Standard Deviation 1.93
|
1.34 seconds
Standard Deviation 2.62
|
|
Change From Baseline in Tear Break-up Time (TBUT)
Baseline
|
4.77 seconds
Standard Deviation 1.68
|
4.93 seconds
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
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).
Outcome measures
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in Corneal Staining Score
Baseline
|
4.49 score on a scale
Standard Deviation 3.39
|
4.51 score on a scale
Standard Deviation 3.29
|
|
Change From Baseline in Corneal Staining Score
Change at Day 90
|
-1.49 score on a scale
Standard Deviation 2.37
|
-0.58 score on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: ITT population included all randomized participants. "n" in the category is the number of participants with data available at the given time-point.
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).
Outcome measures
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in Conjunctival Staining Score
Baseline
|
6.73 score on a scale
Standard Deviation 5.65
|
5.87 score on a scale
Standard Deviation 4.46
|
|
Change From Baseline in Conjunctival Staining Score
Change at Day 90
|
-1.76 score on a scale
Standard Deviation 4.42
|
-1.18 score on a scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: ITT population included all randomized participants. "n" is the number of participants in the category with data available at the given time-point.
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).
Outcome measures
| Measure |
OM3 Tear
n=120 Participants
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.
|
REFRESH OPTIVE® ADVANCED
n=122 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Schirmer Test
Baseline
|
9.91 mm
Standard Deviation 7.10
|
9.85 mm
Standard Deviation 6.82
|
|
Change From Baseline in the Schirmer Test
Change at Day 90
|
1.40 mm
Standard Deviation 7.13
|
1.38 mm
Standard Deviation 7.21
|
Adverse Events
OM3 Tear
REFRESH OPTIVE® ADVANCED
Serious adverse events
| Measure |
OM3 Tear
n=120 participants at risk
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.
|
REFRESH OPTIVE® ADVANCED
n=122 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.83%
1/120 • 120 Days
|
0.00%
0/122 • 120 Days
|
|
Gastrointestinal disorders
Diverticulum
|
0.83%
1/120 • 120 Days
|
0.00%
0/122 • 120 Days
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/120 • 120 Days
|
0.82%
1/122 • 120 Days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/120 • 120 Days
|
0.82%
1/122 • 120 Days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER