Trial · NCT04918823
Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
NCT04918823, Phase 1, Phase 2, Completed, Boston Sight; results first posted 2025-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device. Trials, record NCT04918823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04918823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
- NCT number
- NCT04918823
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Boston Sight
- Conditions
- Ocular Surface Disease
- Interventions
- Restasis
- First posted
- 2021-06-09
- Last updated
- 2025-01-13
- Results first posted
- 2025-01-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) | 1 month post initiation change in OSDI score | 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. |
| Primary | Corneal Staining | at baseline and at 1-month post treatment initiation | 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. |
| Primary | Conjunctival Staining | baseline and 1-month post treatment initiation | 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. |
| Primary | Visual Acuity | at baseline and 1-month post treatment initiation | 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. |
| Primary | Conjunctival Redness | baseline and one month post treatment initiation | 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). |
| Primary | Tolerability Questionnaire Score | baseline and one month post initiation treatment | 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). |
| Primary | Automated Conjunctival Redness Without PROSE Device on the Eye | baseline and one month post treatment initiation | 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). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) | 1 month post initiation change in OSDI score | Subjects who completed the study | score on a scale | MEAN |
| PRIMARY | Corneal Staining | at baseline and at 1-month post treatment initiation | Subjects who completed the study | score on a scale | MEAN |
| PRIMARY | Conjunctival Staining | baseline and 1-month post treatment initiation | Subjects who completed the study | score on a scale | MEAN |
| PRIMARY | Visual Acuity | at baseline and 1-month post treatment initiation | Subjects who completed the study | score on a logMAR scale | MEAN |
| PRIMARY | Conjunctival Redness | baseline and one month post treatment initiation | All subjects who completed study | score on a scale | MEAN |
| PRIMARY | Tolerability Questionnaire Score | baseline and one month post initiation treatment | Subjects who completed the study | tolerability score | MEAN |
| PRIMARY | Automated Conjunctival Redness Without PROSE Device on the Eye | baseline and one month post treatment initiation | 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 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Surface Disease Index (OSDI) Score Change (1 Month Post Treatment Initiation) | Single Arm | -3.83 | Standard Error 6.87 | score on a scale | |
| Corneal Staining | Single Arm | Baseline corneal staining (NEI grading system) | 11.89 | Standard Deviation 5.11 | score on a scale |
| Corneal Staining | Single Arm | 1-month post treatment initiation corneal staining (NEI grading system) | 5.22 | Standard Deviation 4.49 | score on a scale |
| Conjunctival Staining | Single Arm | Conjunctival staining (NEI grading system) at baseline | 12.22 | Standard Deviation 10.49 | score on a scale |
| Conjunctival Staining | Single Arm | Conjunctival staining (NEI grading system) at 1-month post treatment initiation | 7.11 | Standard Deviation 7.74 | score on a scale |
| Visual Acuity | Single Arm | BCVA baseline | 0.359 | Standard Deviation 0.261 | score on a logMAR scale |
| Visual Acuity | Single Arm | BCVA final | 0.353 | Standard Deviation 0.320 | score on a logMAR scale |
| Conjunctival Redness | Single Arm | Conjunctival redness (modified Efron scale) at baseline | 16.78 | Standard Deviation 8.11 | score on a scale |
| Conjunctival Redness | Single Arm | Conjunctival redness (modified Efron scale) at 1 month post treatment initiation | 10.2 | Standard Deviation 7.21 | score on a scale |
| Tolerability Questionnaire Score | Single Arm | Total tolerability questionnaire score at baseline | 46.22 | Standard Deviation 11.40 | tolerability score |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm | 10 | |
| Overall Study | COMPLETED | Single Arm | 9 | |
| Overall Study | NOT COMPLETED | Single Arm | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ocular burning and stinging | Eye disorders | Arm One | 1 | 10 | 1 |
| serious | ocular burning and stinging | Eye disorders | Arm One | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm One | 0 | 10 |
| Total, other adverse events | Arm One | 1 | 10 |
| Total, serious adverse events | Arm One | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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