Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refresh Optive® Gel Drops | Experimental | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
|
| REFRESH LIQUIGEL® | Active Comparator | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refresh Optive® Gel Drops | Drug | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Baseline, Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the OSDI© Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Bay Eye Associates | Petaluma | California | 94954 | United States | ||
| Eric M. White, OD, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30573298 | Background | Lievens C, Berdy G, Douglass D, Montaquila S, Lin H, Simmons P, Carlisle-Wilcox C, Vehige J, Haque S. Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter, double-masked, randomized 30-day study. Cont Lens Anterior Eye. 2019 Aug;42(4):443-449. doi: 10.1016/j.clae.2018.12.003. Epub 2018 Dec 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Refresh Optive® Gel Drops | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| FG001 | REFRESH LIQUIGEL® | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| REFRESH LIQUIGEL® | Drug | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
|
| Baseline, Day 7 |
| Change From Baseline in Tear Break-up Time (TBUT) | TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient. | Baseline, Day 30 |
| Change From Baseline in the Combined Corneal and Conjunctival Staining Scores | The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject. | Baseline, Day 30 |
| Change From Baseline in the Schirmer Test | The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject. | Baseline, Day 30 |
| San Diego |
| California |
| 92123 |
| United States |
| Eye Center Northeast | Bangor | Maine | 04401 | United States |
| Moyes Eye Center, PC | Kansas City | Missouri | 64154 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| David W. Ferris & Associates, Inc. | Warwick | Rhode Island | 02888 | United States |
| Primary Eyecare Group, PC | Brentwood | Tennessee | 37027 | United States |
| The Eye Center at Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All 188 randomized patients were included in the Intent-to Treat (ITT) and safety populations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Refresh Optive® Gel Drops | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| BG001 | REFRESH LIQUIGEL® | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 the Ocular Surface Disease Index© (OSDI©) Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Intent-to-Treat: All randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 30 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the OSDI© Score | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Intent-to-Treat: All randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 7 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Tear Break-up Time (TBUT) | TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient. | Intent-to-Treat: All randomized patients | Posted | Mean | Standard Deviation | Seconds | Baseline, Day 30 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Combined Corneal and Conjunctival Staining Scores | The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject. | Intent-to-Treat: All randomized patients | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 30 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Schirmer Test | The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject. | Intent-to-Treat: All randomized patients | Posted | Mean | Standard Deviation | mm/5 min | Baseline, Day 30 |
|
|
Adverse events were recorded from Screening through Day 30.
The Safety Population included all patients who received at least 1 dose of the study treatment. The Safety Population was used to assess adverse events and serious adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Refresh Optive® Gel Drops | Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 0 | 94 | 7 | 94 | ||
| EG001 | REFRESH LIQUIGEL® | REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days. | 1 | 94 | 5 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyphaema | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 18.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Robinson | Allergan plc | 1-714-246-6415 | Robinson_Michael@Allergan.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
|
| More than 40 years |
|
| Male |
|
|
|
| Counts |
|---|
| Participants |
|
|
|