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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.
For this study, all subjects will receive Restasis (Cyclosporine ophthalmic emulsion 0.05%). One drop of the dispensed study drop will be instilled in the PROSE lens reservoir twice a day and the remainder of the reservoir will be filled with normal saline (0.9% sodium chloride solution). In order to standardize solutions used in the PROSE reservoir, all patients recruited will be either currently using or will be switched to buffered preservative-free normal saline (Purilens, Lifestyle Inc., pH 7.46 ) to better match the reported pH of RESTASIS (pH 6.5-8.05 ).
Outcomes will include subjective responses regarding the subject's symptoms and visual function in addition to the objective assessments of the health of the ocular surface seen on clinical examination. Results will be measured at baseline, after 1 week, and after 1 month of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | All subjects will receive Restasis in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restasis | Drug | Subject will use one drop of Restasis in the lens before insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) | The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. | 1 month post initiation change in OSDI score |
| Corneal Staining | Corneal fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading corneal fluorescein staining which divides the corneal surface into 5 areas [central, superior, nasal, inferior, temporal]. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of cornea. The scores from each corneal area are totaled to determine the total corneal staining score in each eye. The total corneal staining score has a minimum score of zero (better outcome) and a maximum score of 15 (worse outcome) for an individual eye. | at baseline and at 1-month post treatment initiation |
| Conjunctival Staining | Conjunctival fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading conjunctival fluorescein staining which divides the conjunctival surface into 6 areas. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of conjunctiva. The scores from each conjunctival area are totaled to determine the total conjunctival staining score in each eye. The total conjunctival staining score has a minimum score of zero (better outcome) and a maximum score of 18 (worse outcome) for an individual eye. | baseline and 1-month post treatment initiation |
| Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel C Brocks, MD | Boston Sight | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BostonSight | Needham | Massachusetts | 02494 | United States |
There is no IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | All subjects will receive Restasis in this study Restasis: Subject will use one drop of Restasis in the lens before insertion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) | The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. | Subjects who completed the study | Posted | Mean | Standard Error | score on a scale | 1 month post initiation change in OSDI score |
|
|
1 month
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Arm One | One subject withdrew from the study for ocular burning and stinging. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular burning and stinging | Eye disorders | Non-systematic Assessment | Subject experienced ocular burning and stinging |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular burning and stinging | Eye disorders | Burning and stinging | Systematic Assessment | One subject experienced ocular burning and stinging and was withdrawn from the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Brocks | BostonSight | 7817267337 | dbrocks@bostonsight.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2024 | Oct 14, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2024 | Oct 14, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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All subjects will receive study drug to be used in their device.
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Subjects vision was tested using Snellen visual acuity chart (converted to LogMAR scale) pre and post initiation of 0.05% cyclosporine treatment. The LogMAR scale ranges from +3.00 to -0.30. A Zero LogMAR indicates standard 20/20 vision. More negative logMAR scale vision indicates better vision. More positive logMAR scale vision indicates worse vision. Legal blindness is defined as a best-corrected visual acuity of +1.0 LogMAR pr worse in the better seeing eye.
| at baseline and 1-month post treatment initiation |
| Conjunctival Redness | The Efron Grading Scales for Contact Lens Complications includes a standardized method for quantifying the level of conjunctival redness noted on slit lamp examination. The scale ranges, in whole numbers, from 0 to 4, with 0 indicating that conjunctival redness is not present (better outcome) and 4 indicating that the most severe redness is present (worse outcome). | baseline and one month post treatment initiation |
| Tolerability Questionnaire Score | Subjects completed questionnaires regarding PROSE device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome), measured pre and post initiation of 0.05% cyclosporine treatment. Total tolerability score is a composite score sum of SIX questions (maximum score of 60). | baseline and one month post initiation treatment |
| Automated Conjunctival Redness Without PROSE Device on the Eye | Conjunctival redness score measured using the automated imaging system Keratograph 5M R-Scan. The Keratograph 5M R-scan is an imaging device which classifies bulbar and limbal conjunctival redness. The R-Scan detects blood vessels in the conjunctiva and evaluates the degree of redness. The minimum score per eye is 0 (no redness present, better outcome), while the maximum score per eye is 4 (most severe redness present, worse outcome). | baseline and one month post treatment initiation |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dry eye | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Corneal Staining | Corneal fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading corneal fluorescein staining which divides the corneal surface into 5 areas [central, superior, nasal, inferior, temporal]. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of cornea. The scores from each corneal area are totaled to determine the total corneal staining score in each eye. The total corneal staining score has a minimum score of zero (better outcome) and a maximum score of 15 (worse outcome) for an individual eye. | Subjects who completed the study | Posted | Mean | Standard Deviation | score on a scale | at baseline and at 1-month post treatment initiation | eyes | eyes |
|
|
|
| Primary | Conjunctival Staining | Conjunctival fluorescein staining, pre and post initiation of 0.05% cyclosporine treatment, is measured using the National Eye Institute (NEI) grading system. The NEI grading scale is a system for grading conjunctival fluorescein staining which divides the conjunctival surface into 6 areas. A standardized grading system of 0 to 3, with 0 being no staining (better outcome) and 3 being severe staining (worse outcome), is used for each of the areas of conjunctiva. The scores from each conjunctival area are totaled to determine the total conjunctival staining score in each eye. The total conjunctival staining score has a minimum score of zero (better outcome) and a maximum score of 18 (worse outcome) for an individual eye. | Subjects who completed the study | Posted | Mean | Standard Deviation | score on a scale | baseline and 1-month post treatment initiation | eyes | eyes |
|
|
|
| Primary | Visual Acuity | Subjects vision was tested using Snellen visual acuity chart (converted to LogMAR scale) pre and post initiation of 0.05% cyclosporine treatment. The LogMAR scale ranges from +3.00 to -0.30. A Zero LogMAR indicates standard 20/20 vision. More negative logMAR scale vision indicates better vision. More positive logMAR scale vision indicates worse vision. Legal blindness is defined as a best-corrected visual acuity of +1.0 LogMAR pr worse in the better seeing eye. | Subjects who completed the study | Posted | Mean | Standard Deviation | score on a logMAR scale | at baseline and 1-month post treatment initiation | eyes | eyes |
|
|
|
| Primary | Conjunctival Redness | The Efron Grading Scales for Contact Lens Complications includes a standardized method for quantifying the level of conjunctival redness noted on slit lamp examination. The scale ranges, in whole numbers, from 0 to 4, with 0 indicating that conjunctival redness is not present (better outcome) and 4 indicating that the most severe redness is present (worse outcome). | All subjects who completed study | Posted | Mean | Standard Deviation | score on a scale | baseline and one month post treatment initiation | eyes | eyes |
|
|
|
| Primary | Tolerability Questionnaire Score | Subjects completed questionnaires regarding PROSE device comfort and fit (Tolerability Questionnaire, scale 0 to 10, higher score means better outcome), measured pre and post initiation of 0.05% cyclosporine treatment. Total tolerability score is a composite score sum of SIX questions (maximum score of 60). | Subjects who completed the study | Posted | Mean | Standard Deviation | tolerability score | baseline and one month post initiation treatment |
|
|
|
| Primary | Automated Conjunctival Redness Without PROSE Device on the Eye | Conjunctival redness score measured using the automated imaging system Keratograph 5M R-Scan. The Keratograph 5M R-scan is an imaging device which classifies bulbar and limbal conjunctival redness. The R-Scan detects blood vessels in the conjunctiva and evaluates the degree of redness. The minimum score per eye is 0 (no redness present, better outcome), while the maximum score per eye is 4 (most severe redness present, worse outcome). | Sixteen of the eighteen study eyes (8 participants) had adequate K5MRS image acquisition for analysis. Image acquisition was not obtained (machine unable to acquire) for several conjunctival sections at several time points for one subject, so this subject was excluded from the K5MRS analysis | Posted | Mean | Standard Deviation | score on a scale | baseline and one month post treatment initiation | eyes | eyes |
|
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| 0 |
| 10 |
| 1 |
| 10 |
| 1 |
| 10 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |