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This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTIVE FUSION™ | Active Comparator | 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. |
|
| VISMED® Multi | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboxymethylcellulose 0.5%/glycerin 0.9% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28452989 | Background | Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | VISMED® Multi |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 35 |
|
Not provided
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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|
| sodium hyaluronate 0.18% | Drug | 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. |
|
|
| Baseline, Month 3 |
| 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. | Baseline, Day 35 |
| 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). | Baseline, Day 35 |
| 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). | Baseline, Day 35, Month 3 |
| 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). | Baseline, Day 35, Month 3 |
| 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). | Day 35 |
| 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). | Day 35, Month 3 |
| 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). | Baseline, Day 35 |
| 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. | Baseline, Day 35, Month 3 |
| 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). | Baseline, Day 35, Month 3 |
| 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). | Baseline, Day 35, Month 3 |
| 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). | Baseline, Day 35, Month 3 |
| Study Product Use | The number of times the study product is administered per day is recorded. | Day 8, Day 35, Month 3 |
| London |
| United Kingdom |
| Other Reasons |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. |
| OG001 | 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. |
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 3 |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 35 |
|
|
|
| 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). | 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 | Posted | Mean | Standard Deviation | Millimeters (mm)/5 Minutes | Baseline, Day 35 |
|
|
|
| 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). | 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 | Posted | Number | Subjects | Baseline, Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Number | Subjects | Baseline, Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Number | Subjects | Day 35 |
|
|
|
| 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). | 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 | Posted | Number | Subjects | Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Mean | Standard Deviation | Seconds | Baseline, Day 35 |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 35, Month 3 |
|
|
|
| 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). | 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 | Posted | Number | Subjects | Baseline, Day 35, Month 3 |
|
|
|
| Secondary | Study Product Use | The number of times the study product is administered per day is recorded. | 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 | Posted | Mean | Standard Deviation | Number of Times/Day | Day 8, Day 35, Month 3 |
|
|
|
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | 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. | 1 | 40 | 6 | 40 |
| Eye Discharge | Eye disorders | Non-systematic Assessment |
|
| Eye Irritation | Eye disorders | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | Non-systematic Assessment |
|
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.
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D002241 |
| Carbohydrates |
| Baseline Stinging/Burning - Moderate (N=32,28) |
|
| Baseline Stinging/Burning - Severe (N=32,28) |
|
| Baseline Stinging/Burning - Very Severe (N=32,28) |
|
| Day 35 Stinging/Burning - None |
|
| Day 35 Stinging/Burning - Mild |
|
| Day 35 Stinging/Burning - Moderate |
|
| Day 35 Stinging/Burning - Severe |
|
| Day 35 Stinging/Burning - Very Severe |
|
| Month 3 Stinging/Burning - None |
|
| Month 3 Stinging/Burning - Mild |
|
| Month 3 Stinging/Burning - Moderate |
|
| Month 3 Stinging/Burning - Severe |
|
| Month 3 Stinging/Burning - Very Severe |
|
| Baseline Itching - None (N=32,28) |
|
| Baseline Itching - Mild (N=32,28) |
|
| Baseline Itching - Moderate (N=32,28) |
|
| Baseline Itching - Severe (N=32,28) |
|
| Baseline Itching - Very Severe (N=32,28) |
|
| Day 35 Itching- None |
|
| Day 35 Itching- Mild |
|
| Day 35 Itching- Moderate |
|
| Day 35 Itching- Severe |
|
| Day 35 Itching- Very Severe |
|
| Month 3 Itching- None |
|
| Month 3 Itching- Mild |
|
| Month 3 Itching- Moderate |
|
| Month 3 Itching- Severe |
|
| Month 3 Itching- Very Severe |
|
| Baseline Sandiness/Grittiness - None (N=32,28) |
|
| Baseline Sandiness/Grittiness - Mild (N=32,28) |
|
| Baseline Sandiness/Grittiness - Moderate (N=32,28) |
|
| Baseline Sandiness/Grittiness - Severe (N=32,28) |
|
| Bsln Sandiness/Grittiness-Very Severe (N=32,28) |
|
| Day 35 Sandiness/Grittiness - None |
|
| Day 35 Sandiness/Grittiness - Mild |
|
| Day 35 Sandiness/Grittiness - Moderate |
|
| Day 35 Sandiness/Grittiness - Severe |
|
| Day 35 Sandiness/Grittiness - Very Severe |
|
| Month 3 Sandiness/Grittiness - None |
|
| Month 3 Sandiness/Grittiness - Mild |
|
| Month 3 Sandiness/Grittiness - Moderate |
|
| Month 3 Sandiness/Grittiness - Severe |
|
| Month 3 Sandiness/Grittiness - Very Severe |
|
| Baseline Blurred Vision - None (N=32,28) |
|
| Baseline Blurred Vision - Mild (N=32,28) |
|
| Baseline Blurred Vision - Moderate (N=32,28) |
|
| Baseline Blurred Vision - Severe (N=32,28) |
|
| Baseline Blurred Vision - Very Severe (N=32,28) |
|
| Day 35 Blurred Vision - None |
|
| Day 35 Blurred Vision - Mild |
|
| Day 35 Blurred Vision - Moderate |
|
| Day 35 Blurred Vision - Severe |
|
| Day 35 Blurred Vision - Very Severe |
|
| Month 3 Blurred Vision - None |
|
| Month 3 Blurred Vision - Mild |
|
| Month 3 Blurred Vision - Moderate |
|
| Month 3 Blurred Vision - Severe |
|
| Month 3 Blurred Vision - Very Severe |
|
| Baseline Dryness - None (N=32,28) |
|
| Baseline Dryness - Mild (N=32,28) |
|
| Baseline Dryness - Moderate (N=32,28) |
|
| Baseline Dryness - Severe (N=32,28) |
|
| Baseline Dryness - Very Severe (N=32,28) |
|
| Day 35 Dryness - None |
|
| Day 35 Dryness - Mild |
|
| Day 35 Dryness - Moderate |
|
| Day 35 Dryness - Severe |
|
| Day 35 Dryness - Very Severe |
|
| Month 3 Dryness - None |
|
| Month 3 Dryness - Mild |
|
| Month 3 Dryness - Moderate |
|
| Month 3 Dryness - Severe |
|
| Month 3 Dryness - Very Severe |
|
| Baseline Light Sensitivity - None (N=32,28) |
|
| Baseline Light Sensitivity - Mild (N=32,28) |
|
| Baseline Light Sensitivity - Moderate (N=32,28) |
|
| Baseline Light Sensitivity - Severe (N=32,28) |
|
| Baseline Light Sensitivity - Very Severe (N=32,28) |
|
| Day 35 Light Sensitivity - None |
|
| Month 3 Light Sensitivity - Severe |
|
| Month 3 Light Sensitivity - Very Severe |
|
| Day 35 Light Sensitivity - Mild |
|
| Day 35 Light Sensitivity - Moderate |
|
| Day 35 Light Sensitivity - Severe |
|
| Day 35 Light Sensitivity - Very Severe |
|
| Month 3 Light Sensitivity - None |
|
| Month 3 Light Sensitivity - Mild |
|
| Month 3 Light Sensitivity - Moderate |
|
| Baseline Painful or Sore - None (N=31,28) |
|
| Baseline Painful or Sore - Mild (N=31,28) |
|
| Baseline Painful or Sore - Moderate (N=31,28) |
|
| Baseline Painful or Sore - Severe (N=31,28) |
|
| Baseline Painful or Sore - Very Severe (N=31,28) |
|
| Day 35 Painful or Sore - None |
|
| Day 35 Painful or Sore - Mild |
|
| Day 35 Painful or Sore - Moderate |
|
| Day 35 Painful or Sore - Severe |
|
| Day 35 Painful or Sore - Very Severe |
|
| Month 3 Painful or Sore - None |
|
| Month 3 Painful or Sore - Mild |
|
| Month 3 Painful or Sore - Moderate |
|
| Month 3 Painful or Sore - Severe |
|
| Month 3 Painful or Sore - Very Severe (N=34,31) |
|
| Baseline Other - None (N=3,1) |
|
| Baseline Other - Mild (N=3,1) |
|
| Baseline Other - Moderate (N=3,1) |
|
| Baseline Other - Severe (N=3,1) |
|
| Baseline Other - Very Severe (N=3,1) |
|
| Day 35 Other - None (N=1,3) |
|
| Day 35 Other - Mild (N=1,3) |
|
| Day 35 Other - Moderate (N=1,3) |
|
| Day 35 Other - Severe (N=1,3) |
|
| Day 35 Other - Very Severe (N=1,3) |
|
| Month 3 Other - None (N=1,3) |
|
| Month 3 Other - Mild (N=1,3) |
|
| Month 3 Other - Moderate (N=1,3) |
|
| Month 3 Other - Severe (N=1,3) |
|
| Month 3 Other - Very Severe (N=1,3) |
|
| Day 35 - About the Same |
|
| Day 35 - Improved |
|
| Day 35 - Much Improved |
|
| Month 3 - Much Worse |
|
| Month 3 - Worse |
|
| Month 3 - About the Same |
|
| Month 3 - Improved |
|
| Month 3 - Much Improved |
|
| Liked - Neither Agree nor Disagree (N=35,30) |
|
| Liked - Disagree (N=35,30) |
|
| Liked - Strongly Disagree (N=35,30) |
|
| Comfortable - Strongly Agree |
|
| Comfortable - Agree |
|
| Comfortable - Neither Agree nor Disagree |
|
| Comfortable - Disagree |
|
| Comfortable - Strongly Disagree |
|
| Day 35 - Poor |
|
| Day 35 - Very Poor |
|
| Month 3 - Very Satisfactory |
|
| Month 3 - Satisfactory |
|
| Month 3 - Poor |
|
| Month 3 - Very Poor |
|
| Day 35 - Work Productivity (N=11,9) |
|
| Day 35 - Activity Impairment (N=34,31) |
|
| Month 3 - Work Productivity (N=11,10) |
|
| Month 3 - Activity Impairment |
|
| Change from Baseline at Month 3 |
|
| Change from Baseline at Month 3 - Temporal |
|
| Baseline - Nasal |
|
| Change from Baseline at Day 35 - Nasal |
|
| Change from Baseline at Month 3 - Nasal |
|
| Baseline - Mild |
|
| Baseline - Moderate |
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| Baseline Severe |
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| Day 35 - None |
|
| Day 35 - Trace |
|
| Day 35 - Mild |
|
| Day 35 - Moderate |
|
| Day 35 - Severe |
|
| Month 3 - None |
|
| Month 3 - Trace |
|
| Month 3 - Mild |
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| Month 3 - Moderate |
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| Month 3 - Severe |
|
| Month 3 |
|