Trial Outcomes & Findings for A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye (NCT NCT02117687)
NCT ID: NCT02117687
Last Updated: 2019-04-18
Results Overview
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Day 35
Results posted on
2019-04-18
Participant Flow
Participant milestones
| Measure |
OPTIVE FUSION™
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
OPTIVE FUSION™
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Other Reasons
|
1
|
1
|
Baseline Characteristics
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Baseline characteristics by cohort
| Measure |
OPTIVE FUSION™
n=40 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=40 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
17 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Age, Customized
≥65 years
|
23 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 35Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Global Ocular Staining Score in the Study Eye
Baseline
|
5.2 Scores on a Scale
Standard Deviation 1.11
|
5.2 Scores on a Scale
Standard Deviation 1.21
|
|
Change From Baseline in Global Ocular Staining Score in the Study Eye
Change from Baseline at Day 35
|
-1.5 Scores on a Scale
Standard Deviation 1.54
|
-1.6 Scores on a Scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Global Ocular Staining Score in the Study Eye
Baseline
|
5.2 Scores on a Scale
Standard Deviation 1.11
|
5.2 Scores on a Scale
Standard Deviation 1.21
|
|
Change From Baseline in Global Ocular Staining Score in the Study Eye
Change from Baseline at Day 35
|
-2.5 Scores on a Scale
Standard Deviation 2.23
|
-2.4 Scores on a Scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Baseline, Day 35Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. 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 and a positive number change from baseline represents a worsening.
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Baseline
|
45.5 Scores on a Scale
Standard Deviation 22.02
|
44.4 Scores on a Scale
Standard Deviation 17.60
|
|
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Change from Baseline at Day 35
|
-10.3 Scores on a Scale
Standard Deviation 13.51
|
-12.9 Scores on a Scale
Standard Deviation 13.13
|
SECONDARY outcome
Timeframe: Baseline, Day 35Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in the Schirmer Test in the Study Eye
Baseline
|
11.1 Millimeters (mm)/5 Minutes
Standard Deviation 10.22
|
8.7 Millimeters (mm)/5 Minutes
Standard Deviation 7.29
|
|
Change From Baseline in the Schirmer Test in the Study Eye
Change from Baseline at Day 35
|
0.1 Millimeters (mm)/5 Minutes
Standard Deviation 7.74
|
1.0 Millimeters (mm)/5 Minutes
Standard Deviation 5.44
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Stinging/Burning - None (N=32,28)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Stinging/Burning - Mild (N=32,28)
|
7 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Stinging/Burning - Moderate (N=32,28)
|
17 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Stinging/Burning - Severe (N=32,28)
|
7 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Stinging/Burning - Very Severe (N=32,28)
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Stinging/Burning - None
|
5 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Stinging/Burning - Mild
|
12 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Stinging/Burning - Moderate
|
17 Subjects
|
17 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Stinging/Burning - Severe
|
1 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Stinging/Burning - Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Stinging/Burning - None
|
5 Subjects
|
6 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Stinging/Burning - Mild
|
14 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Stinging/Burning - Moderate
|
15 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Stinging/Burning - Severe
|
1 Subjects
|
6 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Stinging/Burning - Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Itching - None (N=32,28)
|
6 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Itching - Mild (N=32,28)
|
8 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Itching - Moderate (N=32,28)
|
12 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Itching - Severe (N=32,28)
|
6 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Itching - Very Severe (N=32,28)
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Itching- None
|
10 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Itching- Mild
|
8 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Itching- Moderate
|
15 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Itching- Severe
|
2 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Itching- Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Itching- None
|
10 Subjects
|
10 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Itching- Mild
|
12 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Itching- Moderate
|
11 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Itching- Severe
|
2 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Itching- Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Sandiness/Grittiness - None (N=32,28)
|
2 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Sandiness/Grittiness - Mild (N=32,28)
|
6 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Sandiness/Grittiness - Moderate (N=32,28)
|
19 Subjects
|
12 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Sandiness/Grittiness - Severe (N=32,28)
|
5 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Bsln Sandiness/Grittiness-Very Severe (N=32,28)
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Sandiness/Grittiness - None
|
7 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Sandiness/Grittiness - Mild
|
13 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Sandiness/Grittiness - Moderate
|
14 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Sandiness/Grittiness - Severe
|
1 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Sandiness/Grittiness - Very Severe
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Sandiness/Grittiness - None
|
7 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Sandiness/Grittiness - Mild
|
17 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Sandiness/Grittiness - Moderate
|
9 Subjects
|
15 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Sandiness/Grittiness - Severe
|
2 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Sandiness/Grittiness - Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Blurred Vision - None (N=32,28)
|
11 Subjects
|
10 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Blurred Vision - Mild (N=32,28)
|
8 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Blurred Vision - Moderate (N=32,28)
|
10 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Blurred Vision - Severe (N=32,28)
|
3 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Blurred Vision - Very Severe (N=32,28)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Blurred Vision - None
|
16 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Blurred Vision - Mild
|
10 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Blurred Vision - Moderate
|
8 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Blurred Vision - Severe
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Blurred Vision - Very Severe
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Blurred Vision - None
|
20 Subjects
|
14 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Blurred Vision - Mild
|
7 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Blurred Vision - Moderate
|
6 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Blurred Vision - Severe
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Blurred Vision - Very Severe
|
1 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Dryness - None (N=32,28)
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Dryness - Mild (N=32,28)
|
2 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Dryness - Moderate (N=32,28)
|
13 Subjects
|
10 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Dryness - Severe (N=32,28)
|
13 Subjects
|
12 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Dryness - Very Severe (N=32,28)
|
3 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Dryness - None
|
4 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Dryness - Mild
|
8 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Dryness - Moderate
|
16 Subjects
|
14 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Dryness - Severe
|
7 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Dryness - Very Severe
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Dryness - None
|
2 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Dryness - Mild
|
12 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Dryness - Moderate
|
17 Subjects
|
14 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Dryness - Severe
|
4 Subjects
|
6 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Dryness - Very Severe
|
0 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Light Sensitivity - None (N=32,28)
|
1 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Light Sensitivity - Mild (N=32,28)
|
4 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Light Sensitivity - Moderate (N=32,28)
|
14 Subjects
|
6 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Light Sensitivity - Severe (N=32,28)
|
9 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Light Sensitivity - Very Severe (N=32,28)
|
4 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Light Sensitivity - None
|
5 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Light Sensitivity - Severe
|
5 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Light Sensitivity - Very Severe
|
1 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Light Sensitivity - Mild
|
6 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Light Sensitivity - Moderate
|
18 Subjects
|
11 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Light Sensitivity - Severe
|
5 Subjects
|
7 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Light Sensitivity - Very Severe
|
1 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Light Sensitivity - None
|
5 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Light Sensitivity - Mild
|
16 Subjects
|
10 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Light Sensitivity - Moderate
|
8 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Painful or Sore - None (N=31,28)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Painful or Sore - Mild (N=31,28)
|
12 Subjects
|
8 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Painful or Sore - Moderate (N=31,28)
|
15 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Painful or Sore - Severe (N=31,28)
|
4 Subjects
|
4 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Painful or Sore - Very Severe (N=31,28)
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Painful or Sore - None
|
5 Subjects
|
5 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Painful or Sore - Mild
|
20 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Painful or Sore - Moderate
|
9 Subjects
|
13 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Painful or Sore - Severe
|
1 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Painful or Sore - Very Severe
|
0 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Painful or Sore - None
|
5 Subjects
|
9 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Painful or Sore - Mild
|
17 Subjects
|
3 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Painful or Sore - Moderate
|
10 Subjects
|
16 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Painful or Sore - Severe
|
2 Subjects
|
2 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Painful or Sore - Very Severe (N=34,31)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Other - None (N=3,1)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Other - Mild (N=3,1)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Other - Moderate (N=3,1)
|
1 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Other - Severe (N=3,1)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Baseline Other - Very Severe (N=3,1)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Other - None (N=1,3)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Other - Mild (N=1,3)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Other - Moderate (N=1,3)
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Other - Severe (N=1,3)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Day 35 Other - Very Severe (N=1,3)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Other - None (N=1,3)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Other - Mild (N=1,3)
|
0 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Other - Moderate (N=1,3)
|
1 Subjects
|
0 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Other - Severe (N=1,3)
|
0 Subjects
|
1 Subjects
|
|
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Month 3 Other - Very Severe (N=1,3)
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Day 35 - Much Worse
|
0 Subjects
|
0 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Day 35 - Worse
|
0 Subjects
|
3 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Day 35 - About the Same
|
12 Subjects
|
11 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Day 35 - Improved
|
21 Subjects
|
14 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Day 35 - Much Improved
|
2 Subjects
|
3 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Month 3 - Much Worse
|
0 Subjects
|
1 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Month 3 - Worse
|
0 Subjects
|
3 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Month 3 - About the Same
|
11 Subjects
|
10 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Month 3 - Improved
|
19 Subjects
|
13 Subjects
|
|
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
Month 3 - Much Improved
|
5 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: Day 35Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Liked - Strongly Agree (N=35,30)
|
14 Subjects
|
8 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Liked - Agree (N=35,30)
|
12 Subjects
|
10 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Liked - Neither Agree nor Disagree (N=35,30)
|
6 Subjects
|
9 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Liked - Disagree (N=35,30)
|
2 Subjects
|
2 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Liked - Strongly Disagree (N=35,30)
|
1 Subjects
|
1 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Comfortable - Strongly Agree
|
9 Subjects
|
9 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Comfortable - Agree
|
16 Subjects
|
13 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Comfortable - Neither Agree nor Disagree
|
7 Subjects
|
6 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Comfortable - Disagree
|
2 Subjects
|
2 Subjects
|
|
Subject Assessment of Treatment Acceptability on a 5-Point Scale
Comfortable - Strongly Disagree
|
1 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Day 35 - Very Satisfactory
|
13 Subjects
|
8 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Day 35 - Satisfactory
|
17 Subjects
|
19 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Day 35 - Poor
|
5 Subjects
|
4 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Day 35 - Very Poor
|
0 Subjects
|
0 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Month 3 - Very Satisfactory
|
15 Subjects
|
10 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Month 3 - Satisfactory
|
15 Subjects
|
11 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Month 3 - Poor
|
5 Subjects
|
9 Subjects
|
|
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Month 3 - Very Poor
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Baseline, Day 35Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. 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) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
Baseline
|
5.52 Seconds
Standard Deviation 2.575
|
5.75 Seconds
Standard Deviation 3.146
|
|
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
Change from Baseline at Day 35
|
0.6 Seconds
Standard Deviation 1.66
|
0.7 Seconds
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, who did not adhere to a pre-defined list of protocol violation criteria, and who had data for this data point
The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire Score
Baseline - Work Productivity (N=11,13)
|
3.09 Scores on a Scale
Standard Deviation 1.921
|
3.46 Scores on a Scale
Standard Deviation 3.382
|
|
Work Productivity and Activity Impairment Questionnaire Score
Baseline - Activity Impairment
|
3.91 Scores on a Scale
Standard Deviation 2.035
|
4.35 Scores on a Scale
Standard Deviation 2.550
|
|
Work Productivity and Activity Impairment Questionnaire Score
Day 35 - Work Productivity (N=11,9)
|
2.55 Scores on a Scale
Standard Deviation 1.809
|
2.33 Scores on a Scale
Standard Deviation 1.936
|
|
Work Productivity and Activity Impairment Questionnaire Score
Day 35 - Activity Impairment (N=34,31)
|
3.09 Scores on a Scale
Standard Deviation 2.065
|
3.52 Scores on a Scale
Standard Deviation 2.393
|
|
Work Productivity and Activity Impairment Questionnaire Score
Month 3 - Work Productivity (N=11,10)
|
1.82 Scores on a Scale
Standard Deviation 0.982
|
2.40 Scores on a Scale
Standard Deviation 2.066
|
|
Work Productivity and Activity Impairment Questionnaire Score
Month 3 - Activity Impairment
|
2.14 Scores on a Scale
Standard Deviation 1.630
|
2.77 Scores on a Scale
Standard Deviation 2.232
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Corneal Staining in the Study Eye
Baseline
|
1.7 Scores on a Scale
Standard Deviation 0.68
|
1.9 Scores on a Scale
Standard Deviation 0.65
|
|
Change From Baseline in Corneal Staining in the Study Eye
Change from Baseline at Day 35
|
-0.4 Scores on a Scale
Standard Deviation 0.77
|
-0.7 Scores on a Scale
Standard Deviation 0.83
|
|
Change From Baseline in Corneal Staining in the Study Eye
Change from Baseline at Month 3
|
-0.8 Scores on a Scale
Standard Deviation 0.84
|
-0.9 Scores on a Scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Baseline - Temporal
|
1.7 Scores on a Scale
Standard Deviation 0.64
|
1.6 Scores on a Scale
Standard Deviation 0.81
|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Change from Baseline at Day 35 - Temporal
|
-0.5 Scores on a Scale
Standard Deviation 0.66
|
-0.5 Scores on a Scale
Standard Deviation 0.81
|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Change from Baseline at Month 3 - Temporal
|
-0.8 Scores on a Scale
Standard Deviation 0.79
|
-0.8 Scores on a Scale
Standard Deviation 0.92
|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Baseline - Nasal
|
1.9 Scores on a Scale
Standard Deviation 0.66
|
1.7 Scores on a Scale
Standard Deviation 0.70
|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Change from Baseline at Day 35 - Nasal
|
-0.6 Scores on a Scale
Standard Deviation 0.65
|
-0.5 Scores on a Scale
Standard Deviation 0.68
|
|
Change From Baseline in Conjunctival Staining in the Study Eye
Change from Baseline at Month 3 - Nasal
|
-0.9 Scores on a Scale
Standard Deviation 0.97
|
-0.7 Scores on a Scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Conjunctival Hyperaemia in the Study Eye
Baseline - None
|
8 Subjects
|
8 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Baseline - Trace
|
13 Subjects
|
11 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Baseline - Mild
|
13 Subjects
|
10 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Baseline - Moderate
|
1 Subjects
|
2 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Baseline Severe
|
0 Subjects
|
0 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Day 35 - None
|
17 Subjects
|
12 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Day 35 - Trace
|
9 Subjects
|
10 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Day 35 - Mild
|
9 Subjects
|
8 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Day 35 - Moderate
|
0 Subjects
|
1 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Day 35 - Severe
|
0 Subjects
|
0 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Month 3 - None
|
22 Subjects
|
14 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Month 3 - Trace
|
8 Subjects
|
7 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Month 3 - Mild
|
5 Subjects
|
9 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Month 3 - Moderate
|
0 Subjects
|
1 Subjects
|
|
Conjunctival Hyperaemia in the Study Eye
Month 3 - Severe
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Day 8, Day 35, Month 3Population: Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria
The number of times the study product is administered per day is recorded.
Outcome measures
| Measure |
OPTIVE FUSION™
n=35 Participants
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=31 Participants
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Study Product Use
Day 8
|
3.63 Number of Times/Day
Standard Deviation 1.190
|
3.47 Number of Times/Day
Standard Deviation 0.900
|
|
Study Product Use
Day 35
|
3.77 Number of Times/Day
Standard Deviation 1.285
|
3.39 Number of Times/Day
Standard Deviation 0.761
|
|
Study Product Use
Month 3
|
3.71 Number of Times/Day
Standard Deviation 1.178
|
3.42 Number of Times/Day
Standard Deviation 0.958
|
Adverse Events
OPTIVE FUSION™
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VISMED® Multi
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPTIVE FUSION™
n=40 participants at risk
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=40 participants at risk
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
2.5%
1/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
Other adverse events
| Measure |
OPTIVE FUSION™
n=40 participants at risk
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
VISMED® Multi
n=40 participants at risk
1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
|
|---|---|---|
|
Eye disorders
Dry Eye
|
0.00%
0/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.0%
2/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Eye disorders
Eye Discharge
|
0.00%
0/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.0%
2/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Eye disorders
Eye Irritation
|
5.0%
2/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
5.0%
2/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
|
Eye disorders
Eye Pruritus
|
5.0%
2/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
0.00%
0/40
The Safety Population included all randomized subjects treated with at least one dose of study product. The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs).
|
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