Trial Outcomes & Findings for A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease (NCT NCT02280473)
NCT ID: NCT02280473
Last Updated: 2019-04-16
Results Overview
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
COMPLETED
PHASE3
188 participants
Baseline, Day 30
2019-04-16
Participant Flow
Participant milestones
| Measure |
Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
94
|
|
Overall Study
COMPLETED
|
93
|
91
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Refresh Optive® Gel Drops
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to less than 30 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Customized
30 to 40 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
More than 40 years
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-Treat: All randomized patients
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Baseline
|
42.44 Scores on a Scale
Standard Deviation 11.708
|
40.43 Scores on a Scale
Standard Deviation 11.232
|
|
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Change from Baseline at Day 30
|
-10.29 Scores on a Scale
Standard Deviation 15.864
|
-7.48 Scores on a Scale
Standard Deviation 16.592
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Intent-to-Treat: All randomized patients
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Outcome measures
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Change From Baseline in the OSDI© Score
Baseline
|
42.44 Scores on a Scale
Standard Deviation 11.708
|
40.43 Scores on a Scale
Standard Deviation 11.232
|
|
Change From Baseline in the OSDI© Score
Change from Baseline at Day 7
|
-5.74 Scores on a Scale
Standard Deviation 14.338
|
-2.34 Scores on a Scale
Standard Deviation 12.294
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-Treat: All randomized patients
TBUT is 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. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.
Outcome measures
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT)
Baseline
|
5.38 Seconds
Standard Deviation 1.674
|
5.40 Seconds
Standard Deviation 2.138
|
|
Change From Baseline in Tear Break-up Time (TBUT)
Change from Baseline at Day 30 (N-94, 93)
|
0.84 Seconds
Standard Deviation 1.968
|
0.70 Seconds
Standard Deviation 4.139
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-Treat: All randomized patients
The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
Outcome measures
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Baseline
|
10.9 Scores on a Scale
Standard Deviation 7.24
|
11.8 Scores on a Scale
Standard Deviation 7.16
|
|
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
Change from Baseline at Day 30 (N=93, 91)
|
-1.7 Scores on a Scale
Standard Deviation 4.66
|
-2.0 Scores on a Scale
Standard Deviation 6.12
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-Treat: All randomized patients
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.
Outcome measures
| Measure |
Refresh Optive® Gel Drops
n=94 Participants
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 Participants
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Change From Baseline in the Schirmer Test
Baseline
|
9.98 mm/5 min
Standard Deviation 7.178
|
11.32 mm/5 min
Standard Deviation 8.496
|
|
Change From Baseline in the Schirmer Test
Change from Baseline at Day 30 (N=88, 86)
|
0.89 mm/5 min
Standard Deviation 5.601
|
0.69 mm/5 min
Standard Deviation 6.479
|
Adverse Events
Refresh Optive® Gel Drops
REFRESH LIQUIGEL®
Serious adverse events
| Measure |
Refresh Optive® Gel Drops
n=94 participants at risk
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 participants at risk
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Eye disorders
Hyphaema
|
0.00%
0/94 • Adverse events were recorded from Screening through Day 30.
The Safety Population included all patients who received at least 1 dose of the study treatment. The Safety Population was used to assess adverse events and serious adverse events.
|
1.1%
1/94 • Adverse events were recorded from Screening through Day 30.
The Safety Population included all patients who received at least 1 dose of the study treatment. The Safety Population was used to assess adverse events and serious adverse events.
|
Other adverse events
| Measure |
Refresh Optive® Gel Drops
n=94 participants at risk
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
REFRESH LIQUIGEL®
n=94 participants at risk
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
7.4%
7/94 • Adverse events were recorded from Screening through Day 30.
The Safety Population included all patients who received at least 1 dose of the study treatment. The Safety Population was used to assess adverse events and serious adverse events.
|
5.3%
5/94 • Adverse events were recorded from Screening through Day 30.
The Safety Population included all patients who received at least 1 dose of the study treatment. The Safety Population was used to assess adverse events and serious adverse events.
|
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