A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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. |
Drug: carboxymethylcellulose 0.5%/glycerin 0.9%
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.
Other Names:
|
Active Comparator: 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. |
Drug: sodium hyaluronate 0.18%
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Global Ocular Staining Score in the Study Eye [Baseline, Day 35]
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.
Secondary Outcome Measures
- Change From Baseline in Global Ocular Staining Score in the Study Eye [Baseline, Month 3]
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.
- Change From Baseline in Ocular Surface Disease Index© (OSDI) Score [Baseline, Day 35]
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.
- Change From Baseline in the Schirmer Test in the Study Eye [Baseline, Day 35]
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).
- Subject Assessment of Dry Eye Symptoms on a 5-Point Scale [Baseline, Day 35, Month 3]
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
- Subject Global Assessment of Treatment Efficacy on a 5-Point Scale [Baseline, Day 35, Month 3]
Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).
- Subject Assessment of Treatment Acceptability on a 5-Point Scale [Day 35]
Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
- Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale [Day 35, Month 3]
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
- Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye [Baseline, Day 35]
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).
- Work Productivity and Activity Impairment Questionnaire Score [Baseline, Day 35, Month 3]
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.
- Change From Baseline in Corneal Staining in the Study Eye [Baseline, Day 35, Month 3]
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).
- Change From Baseline in Conjunctival Staining in the Study Eye [Baseline, Day 35, Month 3]
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).
- Conjunctival Hyperaemia in the Study Eye [Baseline, Day 35, Month 3]
Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).
- Study Product Use [Day 8, Day 35, Month 3]
The number of times the study product is administered per day is recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Use of artificial tears for dry eye in both eyes for at least 3 months
-
Use of preservative-free artificial tears at least twice daily for 2 weeks;
Exclusion Criteria:
-
Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
-
Use of punctal plugs or contact lenses in the last month
-
Active ocular allergy within last 2 years
-
Best corrected visual acuity (BCVA) less than 20/200 in either eye
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Paris | France | |||
2 | London | United Kingdom |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
- MAF-AGN-OPH-DE-016
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
STARTED | 40 | 40 |
COMPLETED | 39 | 36 |
NOT COMPLETED | 1 | 4 |
Baseline Characteristics
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi | Total |
---|---|---|---|
Arm/Group Description | 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. | 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 of all reporting groups |
Overall Participants | 40 | 40 | 80 |
Age, Customized (Number) [Number] | |||
<65 years |
17
42.5%
|
25
62.5%
|
42
52.5%
|
≥65 years |
23
57.5%
|
15
37.5%
|
38
47.5%
|
Sex: Female, Male (Count of Participants) | |||
Female |
36
90%
|
33
82.5%
|
69
86.3%
|
Male |
4
10%
|
7
17.5%
|
11
13.8%
|
Outcome Measures
Title | Change From Baseline in Global Ocular Staining Score in the Study Eye |
---|---|
Description | 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. |
Time Frame | Baseline, Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
5.2
(1.11)
|
5.2
(1.21)
|
Change from Baseline at Day 35 |
-1.5
(1.54)
|
-1.6
(1.54)
|
Title | Change From Baseline in Global Ocular Staining Score in the Study Eye |
---|---|
Description | 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. |
Time Frame | Baseline, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
5.2
(1.11)
|
5.2
(1.21)
|
Change from Baseline at Day 35 |
-2.5
(2.23)
|
-2.4
(2.24)
|
Title | Change From Baseline in Ocular Surface Disease Index© (OSDI) Score |
---|---|
Description | 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. |
Time Frame | Baseline, Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
45.5
(22.02)
|
44.4
(17.60)
|
Change from Baseline at Day 35 |
-10.3
(13.51)
|
-12.9
(13.13)
|
Title | Change From Baseline in the Schirmer Test in the Study Eye |
---|---|
Description | 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). |
Time Frame | Baseline, Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
11.1
(10.22)
|
8.7
(7.29)
|
Change from Baseline at Day 35 |
0.1
(7.74)
|
1.0
(5.44)
|
Title | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale |
---|---|
Description | Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe). |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline Stinging/Burning - None (N=32,28) |
0
|
1
|
Baseline Stinging/Burning - Mild (N=32,28) |
7
|
4
|
Baseline Stinging/Burning - Moderate (N=32,28) |
17
|
13
|
Baseline Stinging/Burning - Severe (N=32,28) |
7
|
9
|
Baseline Stinging/Burning - Very Severe (N=32,28) |
1
|
1
|
Day 35 Stinging/Burning - None |
5
|
2
|
Day 35 Stinging/Burning - Mild |
12
|
8
|
Day 35 Stinging/Burning - Moderate |
17
|
17
|
Day 35 Stinging/Burning - Severe |
1
|
3
|
Day 35 Stinging/Burning - Very Severe |
0
|
1
|
Month 3 Stinging/Burning - None |
5
|
6
|
Month 3 Stinging/Burning - Mild |
14
|
5
|
Month 3 Stinging/Burning - Moderate |
15
|
13
|
Month 3 Stinging/Burning - Severe |
1
|
6
|
Month 3 Stinging/Burning - Very Severe |
0
|
1
|
Baseline Itching - None (N=32,28) |
6
|
5
|
Baseline Itching - Mild (N=32,28) |
8
|
7
|
Baseline Itching - Moderate (N=32,28) |
12
|
1
|
Baseline Itching - Severe (N=32,28) |
6
|
3
|
Baseline Itching - Very Severe (N=32,28) |
0
|
2
|
Day 35 Itching- None |
10
|
8
|
Day 35 Itching- Mild |
8
|
7
|
Day 35 Itching- Moderate |
15
|
13
|
Day 35 Itching- Severe |
2
|
2
|
Day 35 Itching- Very Severe |
0
|
1
|
Month 3 Itching- None |
10
|
10
|
Month 3 Itching- Mild |
12
|
8
|
Month 3 Itching- Moderate |
11
|
9
|
Month 3 Itching- Severe |
2
|
3
|
Month 3 Itching- Very Severe |
0
|
1
|
Baseline Sandiness/Grittiness - None (N=32,28) |
2
|
1
|
Baseline Sandiness/Grittiness - Mild (N=32,28) |
6
|
5
|
Baseline Sandiness/Grittiness - Moderate (N=32,28) |
19
|
12
|
Baseline Sandiness/Grittiness - Severe (N=32,28) |
5
|
8
|
Bsln Sandiness/Grittiness-Very Severe (N=32,28) |
0
|
2
|
Day 35 Sandiness/Grittiness - None |
7
|
4
|
Day 35 Sandiness/Grittiness - Mild |
13
|
8
|
Day 35 Sandiness/Grittiness - Moderate |
14
|
13
|
Day 35 Sandiness/Grittiness - Severe |
1
|
4
|
Day 35 Sandiness/Grittiness - Very Severe |
0
|
2
|
Month 3 Sandiness/Grittiness - None |
7
|
8
|
Month 3 Sandiness/Grittiness - Mild |
17
|
4
|
Month 3 Sandiness/Grittiness - Moderate |
9
|
15
|
Month 3 Sandiness/Grittiness - Severe |
2
|
3
|
Month 3 Sandiness/Grittiness - Very Severe |
0
|
1
|
Baseline Blurred Vision - None (N=32,28) |
11
|
10
|
Baseline Blurred Vision - Mild (N=32,28) |
8
|
7
|
Baseline Blurred Vision - Moderate (N=32,28) |
10
|
7
|
Baseline Blurred Vision - Severe (N=32,28) |
3
|
3
|
Baseline Blurred Vision - Very Severe (N=32,28) |
0
|
1
|
Day 35 Blurred Vision - None |
16
|
13
|
Day 35 Blurred Vision - Mild |
10
|
9
|
Day 35 Blurred Vision - Moderate |
8
|
7
|
Day 35 Blurred Vision - Severe |
1
|
1
|
Day 35 Blurred Vision - Very Severe |
0
|
1
|
Month 3 Blurred Vision - None |
20
|
14
|
Month 3 Blurred Vision - Mild |
7
|
9
|
Month 3 Blurred Vision - Moderate |
6
|
5
|
Month 3 Blurred Vision - Severe |
1
|
1
|
Month 3 Blurred Vision - Very Severe |
1
|
2
|
Baseline Dryness - None (N=32,28) |
1
|
1
|
Baseline Dryness - Mild (N=32,28) |
2
|
2
|
Baseline Dryness - Moderate (N=32,28) |
13
|
10
|
Baseline Dryness - Severe (N=32,28) |
13
|
12
|
Baseline Dryness - Very Severe (N=32,28) |
3
|
3
|
Day 35 Dryness - None |
4
|
3
|
Day 35 Dryness - Mild |
8
|
5
|
Day 35 Dryness - Moderate |
16
|
14
|
Day 35 Dryness - Severe |
7
|
7
|
Day 35 Dryness - Very Severe |
0
|
2
|
Month 3 Dryness - None |
2
|
3
|
Month 3 Dryness - Mild |
12
|
5
|
Month 3 Dryness - Moderate |
17
|
14
|
Month 3 Dryness - Severe |
4
|
6
|
Month 3 Dryness - Very Severe |
0
|
3
|
Baseline Light Sensitivity - None (N=32,28) |
1
|
2
|
Baseline Light Sensitivity - Mild (N=32,28) |
4
|
8
|
Baseline Light Sensitivity - Moderate (N=32,28) |
14
|
6
|
Baseline Light Sensitivity - Severe (N=32,28) |
9
|
7
|
Baseline Light Sensitivity - Very Severe (N=32,28) |
4
|
5
|
Day 35 Light Sensitivity - None |
5
|
2
|
Month 3 Light Sensitivity - Severe |
5
|
8
|
Month 3 Light Sensitivity - Very Severe |
1
|
3
|
Day 35 Light Sensitivity - Mild |
6
|
7
|
Day 35 Light Sensitivity - Moderate |
18
|
11
|
Day 35 Light Sensitivity - Severe |
5
|
7
|
Day 35 Light Sensitivity - Very Severe |
1
|
4
|
Month 3 Light Sensitivity - None |
5
|
2
|
Month 3 Light Sensitivity - Mild |
16
|
10
|
Month 3 Light Sensitivity - Moderate |
8
|
8
|
Baseline Painful or Sore - None (N=31,28) |
0
|
1
|
Baseline Painful or Sore - Mild (N=31,28) |
12
|
8
|
Baseline Painful or Sore - Moderate (N=31,28) |
15
|
13
|
Baseline Painful or Sore - Severe (N=31,28) |
4
|
4
|
Baseline Painful or Sore - Very Severe (N=31,28) |
0
|
2
|
Day 35 Painful or Sore - None |
5
|
5
|
Day 35 Painful or Sore - Mild |
20
|
9
|
Day 35 Painful or Sore - Moderate |
9
|
13
|
Day 35 Painful or Sore - Severe |
1
|
2
|
Day 35 Painful or Sore - Very Severe |
0
|
2
|
Month 3 Painful or Sore - None |
5
|
9
|
Month 3 Painful or Sore - Mild |
17
|
3
|
Month 3 Painful or Sore - Moderate |
10
|
16
|
Month 3 Painful or Sore - Severe |
2
|
2
|
Month 3 Painful or Sore - Very Severe (N=34,31) |
0
|
1
|
Baseline Other - None (N=3,1) |
0
|
0
|
Baseline Other - Mild (N=3,1) |
0
|
0
|
Baseline Other - Moderate (N=3,1) |
1
|
0
|
Baseline Other - Severe (N=3,1) |
0
|
0
|
Baseline Other - Very Severe (N=3,1) |
0
|
1
|
Day 35 Other - None (N=1,3) |
0
|
0
|
Day 35 Other - Mild (N=1,3) |
0
|
0
|
Day 35 Other - Moderate (N=1,3) |
1
|
1
|
Day 35 Other - Severe (N=1,3) |
0
|
1
|
Day 35 Other - Very Severe (N=1,3) |
0
|
1
|
Month 3 Other - None (N=1,3) |
0
|
1
|
Month 3 Other - Mild (N=1,3) |
0
|
0
|
Month 3 Other - Moderate (N=1,3) |
1
|
0
|
Month 3 Other - Severe (N=1,3) |
0
|
1
|
Month 3 Other - Very Severe (N=1,3) |
0
|
1
|
Title | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale |
---|---|
Description | Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved). |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Day 35 - Much Worse |
0
|
0
|
Day 35 - Worse |
0
|
3
|
Day 35 - About the Same |
12
|
11
|
Day 35 - Improved |
21
|
14
|
Day 35 - Much Improved |
2
|
3
|
Month 3 - Much Worse |
0
|
1
|
Month 3 - Worse |
0
|
3
|
Month 3 - About the Same |
11
|
10
|
Month 3 - Improved |
19
|
13
|
Month 3 - Much Improved |
5
|
4
|
Title | Subject Assessment of Treatment Acceptability on a 5-Point Scale |
---|---|
Description | Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). |
Time Frame | Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Liked - Strongly Agree (N=35,30) |
14
|
8
|
Liked - Agree (N=35,30) |
12
|
10
|
Liked - Neither Agree nor Disagree (N=35,30) |
6
|
9
|
Liked - Disagree (N=35,30) |
2
|
2
|
Liked - Strongly Disagree (N=35,30) |
1
|
1
|
Comfortable - Strongly Agree |
9
|
9
|
Comfortable - Agree |
16
|
13
|
Comfortable - Neither Agree nor Disagree |
7
|
6
|
Comfortable - Disagree |
2
|
2
|
Comfortable - Strongly Disagree |
1
|
1
|
Title | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale |
---|---|
Description | Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor). |
Time Frame | Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Day 35 - Very Satisfactory |
13
|
8
|
Day 35 - Satisfactory |
17
|
19
|
Day 35 - Poor |
5
|
4
|
Day 35 - Very Poor |
0
|
0
|
Month 3 - Very Satisfactory |
15
|
10
|
Month 3 - Satisfactory |
15
|
11
|
Month 3 - Poor |
5
|
9
|
Month 3 - Very Poor |
0
|
1
|
Title | Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye |
---|---|
Description | 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). |
Time Frame | Baseline, Day 35 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
5.52
(2.575)
|
5.75
(3.146)
|
Change from Baseline at Day 35 |
0.6
(1.66)
|
0.7
(2.00)
|
Title | Work Productivity and Activity Impairment Questionnaire Score |
---|---|
Description | 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. |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline - Work Productivity (N=11,13) |
3.09
(1.921)
|
3.46
(3.382)
|
Baseline - Activity Impairment |
3.91
(2.035)
|
4.35
(2.550)
|
Day 35 - Work Productivity (N=11,9) |
2.55
(1.809)
|
2.33
(1.936)
|
Day 35 - Activity Impairment (N=34,31) |
3.09
(2.065)
|
3.52
(2.393)
|
Month 3 - Work Productivity (N=11,10) |
1.82
(0.982)
|
2.40
(2.066)
|
Month 3 - Activity Impairment |
2.14
(1.630)
|
2.77
(2.232)
|
Title | Change From Baseline in Corneal Staining in the Study Eye |
---|---|
Description | 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). |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline |
1.7
(0.68)
|
1.9
(0.65)
|
Change from Baseline at Day 35 |
-0.4
(0.77)
|
-0.7
(0.83)
|
Change from Baseline at Month 3 |
-0.8
(0.84)
|
-0.9
(1.04)
|
Title | Change From Baseline in Conjunctival Staining in the Study Eye |
---|---|
Description | 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). |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline - Temporal |
1.7
(0.64)
|
1.6
(0.81)
|
Change from Baseline at Day 35 - Temporal |
-0.5
(0.66)
|
-0.5
(0.81)
|
Change from Baseline at Month 3 - Temporal |
-0.8
(0.79)
|
-0.8
(0.92)
|
Baseline - Nasal |
1.9
(0.66)
|
1.7
(0.70)
|
Change from Baseline at Day 35 - Nasal |
-0.6
(0.65)
|
-0.5
(0.68)
|
Change from Baseline at Month 3 - Nasal |
-0.9
(0.97)
|
-0.7
(0.87)
|
Title | Conjunctival Hyperaemia in the Study Eye |
---|---|
Description | Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe). |
Time Frame | Baseline, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Baseline - None |
8
|
8
|
Baseline - Trace |
13
|
11
|
Baseline - Mild |
13
|
10
|
Baseline - Moderate |
1
|
2
|
Baseline Severe |
0
|
0
|
Day 35 - None |
17
|
12
|
Day 35 - Trace |
9
|
10
|
Day 35 - Mild |
9
|
8
|
Day 35 - Moderate |
0
|
1
|
Day 35 - Severe |
0
|
0
|
Month 3 - None |
22
|
14
|
Month 3 - Trace |
8
|
7
|
Month 3 - Mild |
5
|
9
|
Month 3 - Moderate |
0
|
1
|
Month 3 - Severe |
0
|
0
|
Title | Study Product Use |
---|---|
Description | The number of times the study product is administered per day is recorded. |
Time Frame | Day 8, Day 35, Month 3 |
Outcome Measure Data
Analysis Population Description |
---|
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 |
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 31 |
Day 8 |
3.63
(1.190)
|
3.47
(0.900)
|
Day 35 |
3.77
(1.285)
|
3.39
(0.761)
|
Month 3 |
3.71
(1.178)
|
3.42
(0.958)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | 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). | |||
Arm/Group Title | OPTIVE FUSION™ | VISMED® Multi | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
OPTIVE FUSION™ | VISMED® Multi | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
OPTIVE FUSION™ | VISMED® Multi | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 1/40 (2.5%) | ||
Cardiac disorders | ||||
Pericarditis | 0/40 (0%) | 1/40 (2.5%) | ||
Other (Not Including Serious) Adverse Events |
||||
OPTIVE FUSION™ | VISMED® Multi | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/40 (10%) | 6/40 (15%) | ||
Eye disorders | ||||
Dry Eye | 0/40 (0%) | 2/40 (5%) | ||
Eye Discharge | 0/40 (0%) | 2/40 (5%) | ||
Eye Irritation | 2/40 (5%) | 2/40 (5%) | ||
Eye Pruritus | 2/40 (5%) | 0/40 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 | Vice President Medical Affairs, |
---|---|
Organization | Allergan, Inc |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- MAF-AGN-OPH-DE-016