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Restasis · 1 trial · 1 indication
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.
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.
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 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.
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).
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).
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).
| Arm | Type | Description |
|---|---|---|
| Single arm | OTHER | All subjects will receive Restasis in this study |
| Name | Type | Description |
|---|---|---|
| Restasis | DRUG | Subject will use one drop of Restasis in the lens before insertion |
Inclusion Criteria: 1. Written Informed Consent has been obtained prior to any study-related procedures taking place 2. Subject is Male or Female, 18 years of age or older prior to the initial visit 3. Is an established wearer of PROSE devices for \> 6 months in both eyes 4. Has a finalized PROSE l...
Restasis is a small molecule ophthalmic emulsion being studied for Ocular Surface Disease. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated for its potential to treat this condition, though it remains in early-stage clinical testing.
Restasis contains cyclosporine, an immunosuppressant that works by inhibiting calcineurin and reducing T-cell activation. This mechanism helps decrease inflammation on the ocular surface, which is relevant for treating Ocular Surface Disease. The drug is administered as an ophthalmic emulsion.
Restasis is being developed by Sight Sciences, Inc., a company traded on the NASDAQ under the ticker SGHT. The company is conducting clinical research on this ophthalmic emulsion for Ocular Surface Disease. Sight Sciences is responsible for the drug's development program.
Restasis is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Ocular Surface Disease, with one completed Phase 1 trial involving 10 participants.
Restasis has one completed clinical trial registered as NCT04918823, titled 'Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device.' This Phase 1 study enrolled 10 participants with Ocular Surface Disease in the United States. The trial was uncontrolled and not randomized or double-blinded.
Restasis is a cyclosporine ophthalmic emulsion 0.05%. The clinical trial NCT04918823 specifically evaluates this formulation. The drug is being investigated for use in Ocular Surface Disease, and the trial explores its application in a PROSE device for delivery.