Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Brief summary
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
Interventions
DRUGcarboxymethylcellulose 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.
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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). |
Countries
France, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other Reasons | 1 | 1 |
Baseline characteristics
| Characteristic | OPTIVE FUSION™ | VISMED® Multi | Total |
|---|---|---|---|
| Age, Customized <65 years | 17 Participants | 25 Participants | 42 Participants |
| Age, Customized ≥65 years | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Female | 36 Participants | 33 Participants | 69 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 40 | 6 / 40 |
| serious Total, serious adverse events | 0 / 40 | 1 / 40 |
Outcome results
Primary
Change From Baseline in Global Ocular Staining Score in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Global Ocular Staining Score in the Study Eye | Baseline | 5.2 Scores on a Scale | Standard Deviation 1.11 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Global Ocular Staining Score in the Study Eye | Baseline | 5.2 Scores on a Scale | Standard Deviation 1.21 |
| VISMED® Multi | Change From Baseline in Global Ocular Staining Score in the Study Eye | Change from Baseline at Day 35 | -1.6 Scores on a Scale | Standard Deviation 1.54 |
Secondary
Change From Baseline in Conjunctival Staining in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Conjunctival Staining in the Study Eye | Baseline - Temporal | 1.7 Scores on a Scale | Standard Deviation 0.64 |
| OPTIVE FUSION™ | 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 |
| OPTIVE FUSION™ | 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 |
| OPTIVE FUSION™ | Change From Baseline in Conjunctival Staining in the Study Eye | Baseline - Nasal | 1.9 Scores on a Scale | Standard Deviation 0.66 |
| OPTIVE FUSION™ | 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 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Conjunctival Staining in the Study Eye | Change from Baseline at Day 35 - Nasal | -0.5 Scores on a Scale | Standard Deviation 0.68 |
| VISMED® Multi | Change From Baseline in Conjunctival Staining in the Study Eye | Baseline - Temporal | 1.6 Scores on a Scale | Standard Deviation 0.81 |
| VISMED® Multi | Change From Baseline in Conjunctival Staining in the Study Eye | Baseline - Nasal | 1.7 Scores on a Scale | Standard Deviation 0.7 |
| VISMED® Multi | 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 0.81 |
| VISMED® Multi | Change From Baseline in Conjunctival Staining in the Study Eye | Change from Baseline at Month 3 - Nasal | -0.7 Scores on a Scale | Standard Deviation 0.87 |
| VISMED® Multi | 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 0.92 |
Secondary
Change From Baseline in Corneal Staining in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Corneal Staining in the Study Eye | Baseline | 1.7 Scores on a Scale | Standard Deviation 0.68 |
| OPTIVE FUSION™ | 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 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Corneal Staining in the Study Eye | Baseline | 1.9 Scores on a Scale | Standard Deviation 0.65 |
| VISMED® Multi | Change From Baseline in Corneal Staining in the Study Eye | Change from Baseline at Day 35 | -0.7 Scores on a Scale | Standard Deviation 0.83 |
| VISMED® Multi | Change From Baseline in Corneal Staining in the Study Eye | Change from Baseline at Month 3 | -0.9 Scores on a Scale | Standard Deviation 1.04 |
Secondary
Change From Baseline in Global Ocular Staining Score in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Global Ocular Staining Score in the Study Eye | Baseline | 5.2 Scores on a Scale | Standard Deviation 1.11 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Global Ocular Staining Score in the Study Eye | Baseline | 5.2 Scores on a Scale | Standard Deviation 1.21 |
| VISMED® Multi | Change From Baseline in Global Ocular Staining Score in the Study Eye | Change from Baseline at Day 35 | -2.4 Scores on a Scale | Standard Deviation 2.24 |
Secondary
Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Ocular Surface Disease Index© (OSDI) Score | Baseline | 45.5 Scores on a Scale | Standard Deviation 22.02 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Ocular Surface Disease Index© (OSDI) Score | Baseline | 44.4 Scores on a Scale | Standard Deviation 17.6 |
| VISMED® Multi | Change From Baseline in Ocular Surface Disease Index© (OSDI) Score | Change from Baseline at Day 35 | -12.9 Scores on a Scale | Standard Deviation 13.13 |
Secondary
Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye | Baseline | 5.52 Seconds | Standard Deviation 2.575 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye | Baseline | 5.75 Seconds | Standard Deviation 3.146 |
| VISMED® Multi | Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye | Change from Baseline at Day 35 | 0.7 Seconds | Standard Deviation 2 |
Secondary
Change From Baseline in the Schirmer Test in the Study Eye
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Change From Baseline in the Schirmer Test in the Study Eye | Baseline | 11.1 Millimeters (mm)/5 Minutes | Standard Deviation 10.22 |
| OPTIVE FUSION™ | 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 |
| VISMED® Multi | Change From Baseline in the Schirmer Test in the Study Eye | Baseline | 8.7 Millimeters (mm)/5 Minutes | Standard Deviation 7.29 |
| VISMED® Multi | Change From Baseline in the Schirmer Test in the Study Eye | Change from Baseline at Day 35 | 1.0 Millimeters (mm)/5 Minutes | Standard Deviation 5.44 |
Secondary
Conjunctival Hyperaemia in the Study Eye
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Baseline Severe | 0 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Day 35 - Moderate | 0 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Baseline - Trace | 13 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Day 35 - Severe | 0 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Day 35 - None | 17 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Month 3 - None | 22 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Baseline - Moderate | 1 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Month 3 - Trace | 8 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Day 35 - Trace | 9 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Month 3 - Mild | 5 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Baseline - Mild | 13 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Month 3 - Moderate | 0 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Day 35 - Mild | 9 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Month 3 - Severe | 0 Subjects |
| OPTIVE FUSION™ | Conjunctival Hyperaemia in the Study Eye | Baseline - None | 8 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Month 3 - Severe | 0 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Baseline - None | 8 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Baseline - Trace | 11 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Baseline - Mild | 10 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Baseline - Moderate | 2 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Baseline Severe | 0 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Day 35 - None | 12 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Day 35 - Trace | 10 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Day 35 - Mild | 8 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Day 35 - Moderate | 1 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Day 35 - Severe | 0 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Month 3 - None | 14 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Month 3 - Trace | 7 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Month 3 - Mild | 9 Subjects |
| VISMED® Multi | Conjunctival Hyperaemia in the Study Eye | Month 3 - Moderate | 1 Subjects |
Secondary
Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).
Time frame: Day 35, Month 3
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Very Satisfactory | 13 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Satisfactory | 17 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Poor | 5 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Very Poor | 0 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Very Satisfactory | 15 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Satisfactory | 15 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Poor | 5 Subjects |
| OPTIVE FUSION™ | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Very Poor | 0 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Very Poor | 1 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Very Satisfactory | 8 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Very Satisfactory | 10 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Satisfactory | 19 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Poor | 9 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Poor | 4 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Month 3 - Satisfactory | 11 Subjects |
| VISMED® Multi | Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale | Day 35 - Very Poor | 0 Subjects |
Secondary
Study Product Use
The number of times the study product is administered per day is recorded.
Time frame: Day 8, Day 35, Month 3
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Study Product Use | Day 8 | 3.63 Number of Times/Day | Standard Deviation 1.19 |
| OPTIVE FUSION™ | Study Product Use | Day 35 | 3.77 Number of Times/Day | Standard Deviation 1.285 |
| OPTIVE FUSION™ | Study Product Use | Month 3 | 3.71 Number of Times/Day | Standard Deviation 1.178 |
| VISMED® Multi | Study Product Use | Day 8 | 3.47 Number of Times/Day | Standard Deviation 0.9 |
| VISMED® Multi | Study Product Use | Day 35 | 3.39 Number of Times/Day | Standard Deviation 0.761 |
| VISMED® Multi | Study Product Use | Month 3 | 3.42 Number of Times/Day | Standard Deviation 0.958 |
Secondary
Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).
Time frame: Baseline, Day 35, Month 3
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Moderate | 18 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - None | 20 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Mild | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Moderate | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - None (N=32,28) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Mild (N=32,28) | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Moderate (N=32,28) | 13 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Severe (N=32,28) | 13 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Very Severe (N=32,28) | 3 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - None | 4 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Mild | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Moderate | 16 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Severe | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - None | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Mild | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Moderate | 17 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Severe | 4 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - None (N=32,28) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Mild (N=32,28) | 4 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Moderate (N=32,28) | 14 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Severe (N=32,28) | 9 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Very Severe (N=32,28) | 4 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Severe | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Very Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Mild | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Very Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Severe | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Very Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Mild | 16 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Moderate | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - None (N=31,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Mild (N=31,28) | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Moderate (N=31,28) | 15 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Severe (N=31,28) | 4 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Very Severe (N=31,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Mild | 20 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Moderate | 9 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Mild | 17 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Moderate | 10 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Severe | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Very Severe (N=34,31) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - None (N=3,1) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Mild (N=3,1) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Moderate (N=3,1) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Severe (N=3,1) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Very Severe (N=3,1) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - None (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Mild (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Moderate (N=1,3) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Severe (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Very Severe (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - None (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Mild (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Moderate (N=1,3) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Severe (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Very Severe (N=1,3) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Moderate | 17 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - None (N=32,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Mild (N=32,28) | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Moderate (N=32,28) | 17 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Severe (N=32,28) | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Very Severe (N=32,28) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Mild | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - None | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Mild | 14 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Moderate | 15 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - None (N=32,28) | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Mild (N=32,28) | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Moderate (N=32,28) | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Severe (N=32,28) | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Very Severe (N=32,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- None | 10 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Mild | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Moderate | 15 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Severe | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- None | 10 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Mild | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Moderate | 11 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Severe | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - None (N=32,28) | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Mild (N=32,28) | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Moderate (N=32,28) | 19 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Severe (N=32,28) | 5 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Bsln Sandiness/Grittiness-Very Severe (N=32,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - None | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Mild | 13 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Moderate | 14 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Severe | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - None | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Mild | 17 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Moderate | 9 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Severe | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Very Severe | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - None (N=32,28) | 11 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Mild (N=32,28) | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Moderate (N=32,28) | 10 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Severe (N=32,28) | 3 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Very Severe (N=32,28) | 0 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - None | 16 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Mild | 10 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Moderate | 8 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Mild (N=32,28) | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Very Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Very Severe (N=1,3) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - None | 14 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - None (N=1,3) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Mild | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Very Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Moderate | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Mild (N=1,3) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Blurred Vision - Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- None | 10 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - None (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Moderate (N=1,3) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Mild (N=32,28) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - None | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Moderate (N=32,28) | 10 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Severe (N=1,3) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Severe (N=32,28) | 12 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Mild | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Dryness - Very Severe (N=32,28) | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Other - Very Severe (N=1,3) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - None | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - None | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Mild | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Moderate | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Moderate | 14 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - None (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Severe | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Moderate (N=32,28) | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Dryness - Very Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Mild (N=32,28) | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - None | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Severe | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Mild | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Moderate (N=32,28) | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Moderate | 14 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Mild | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Severe | 6 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Severe (N=32,28) | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Dryness - Very Severe | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Itching- Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - None (N=32,28) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Stinging/Burning - Very Severe (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Mild (N=32,28) | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Moderate | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Moderate (N=32,28) | 6 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - None | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Severe (N=32,28) | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - None (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Light Sensitivity - Very Severe (N=32,28) | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Mild | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - None | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Moderate | 17 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Severe | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Moderate | 15 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Very Severe | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Severe | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Mild | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Mild (N=32,28) | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Moderate | 11 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Stinging/Burning - Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Severe | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Severe (N=32,28) | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Light Sensitivity - Very Severe | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - None | 6 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - None | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Moderate (N=32,28) | 12 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Mild | 10 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Mild | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Light Sensitivity - Moderate | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Severe | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - None (N=31,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Moderate | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Mild (N=31,28) | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Sandiness/Grittiness - Severe (N=32,28) | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Moderate (N=31,28) | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Severe | 6 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Severe (N=31,28) | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Mild | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Painful or Sore - Very Severe (N=31,28) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Stinging/Burning - Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - None | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Bsln Sandiness/Grittiness-Very Severe (N=32,28) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Mild | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - None (N=32,28) | 5 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Moderate | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Sandiness/Grittiness - Very Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Mild (N=32,28) | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Painful or Sore - Very Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - None | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - None | 9 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Moderate (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Mild | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - Very Severe (N=32,28) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Moderate | 16 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Severe (N=32,28) | 3 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Mild | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Month 3 Painful or Sore - Very Severe (N=34,31) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Itching - Very Severe (N=32,28) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - None (N=3,1) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Blurred Vision - None (N=32,28) | 10 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Mild (N=3,1) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- None | 8 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Moderate (N=3,1) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Moderate | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Severe (N=3,1) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Mild | 7 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Baseline Other - Very Severe (N=3,1) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Blurred Vision - Severe | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - None (N=1,3) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Moderate | 13 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Mild (N=1,3) | 0 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Sandiness/Grittiness - Severe | 4 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Moderate (N=1,3) | 1 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Itching- Severe | 2 Subjects |
| VISMED® Multi | Subject Assessment of Dry Eye Symptoms on a 5-Point Scale | Day 35 Other - Severe (N=1,3) | 1 Subjects |
Secondary
Subject Assessment of Treatment Acceptability on a 5-Point Scale
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Strongly Agree (N=35,30) | 14 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Agree (N=35,30) | 12 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Neither Agree nor Disagree (N=35,30) | 6 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Disagree (N=35,30) | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Strongly Disagree (N=35,30) | 1 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Strongly Agree | 9 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Agree | 16 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Neither Agree nor Disagree | 7 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Disagree | 2 Subjects |
| OPTIVE FUSION™ | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Strongly Disagree | 1 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Neither Agree nor Disagree | 6 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Strongly Agree (N=35,30) | 8 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Strongly Agree | 9 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Agree (N=35,30) | 10 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Strongly Disagree | 1 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Neither Agree nor Disagree (N=35,30) | 9 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Agree | 13 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Disagree (N=35,30) | 2 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Comfortable - Disagree | 2 Subjects |
| VISMED® Multi | Subject Assessment of Treatment Acceptability on a 5-Point Scale | Liked - Strongly Disagree (N=35,30) | 1 Subjects |
Secondary
Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Worse | 0 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Much Improved | 2 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Much Worse | 0 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Much Worse | 0 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - About the Same | 12 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Worse | 0 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Much Improved | 5 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - About the Same | 11 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Improved | 21 Subjects |
| OPTIVE FUSION™ | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Improved | 19 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Improved | 14 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Much Improved | 4 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Much Worse | 0 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Worse | 3 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - About the Same | 11 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Improved | 13 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Day 35 - Much Improved | 3 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Much Worse | 1 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - Worse | 3 Subjects |
| VISMED® Multi | Subject Global Assessment of Treatment Efficacy on a 5-Point Scale | Month 3 - About the Same | 10 Subjects |
Secondary
Work Productivity and Activity Impairment Questionnaire Score
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Day 35 - Work Productivity (N=11,9) | 2.55 Scores on a Scale | Standard Deviation 1.809 |
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Day 35 - Activity Impairment (N=34,31) | 3.09 Scores on a Scale | Standard Deviation 2.065 |
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Month 3 - Work Productivity (N=11,10) | 1.82 Scores on a Scale | Standard Deviation 0.982 |
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Month 3 - Activity Impairment | 2.14 Scores on a Scale | Standard Deviation 1.63 |
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Baseline - Work Productivity (N=11,13) | 3.09 Scores on a Scale | Standard Deviation 1.921 |
| OPTIVE FUSION™ | Work Productivity and Activity Impairment Questionnaire Score | Baseline - Activity Impairment | 3.91 Scores on a Scale | Standard Deviation 2.035 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Baseline - Work Productivity (N=11,13) | 3.46 Scores on a Scale | Standard Deviation 3.382 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Day 35 - Work Productivity (N=11,9) | 2.33 Scores on a Scale | Standard Deviation 1.936 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Month 3 - Activity Impairment | 2.77 Scores on a Scale | Standard Deviation 2.232 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Day 35 - Activity Impairment (N=34,31) | 3.52 Scores on a Scale | Standard Deviation 2.393 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Baseline - Activity Impairment | 4.35 Scores on a Scale | Standard Deviation 2.55 |
| VISMED® Multi | Work Productivity and Activity Impairment Questionnaire Score | Month 3 - Work Productivity (N=11,10) | 2.40 Scores on a Scale | Standard Deviation 2.066 |