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
Not provided
20 healthy participants will be evaluated for tolerability and safety of a new eye drop formulation for treatment of Dry Eye Syndromes, Oph1 0.5% Cyclosporine A (CsA) compared with Restasis 0.05% CsA ophthalmic formulation.
20 healthy participants will be enrolled to the study and randomized into two groups of 10 participants each. In one group participants will be treated with Oph1 0.5% CsA ophthalmic formulation and in the other group with Restasis 0.05% CsA ophthalmic formulation. Both groups will be treated with the eye drops in the right eye only, twice a day (6-9 hours apart), for four days and once on the fifth day (total of 9 eye drops treatment for each), both groups will have 2 days of washout, and will be crossed to identical course of treatment with the other ophthalmic formulation. All eye drops treatments will be done on the medical site by one of the study staff unblinded to the treatment. The Investigator assessing the ocular signs and the participants will be blinded to study treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Oph1 0.5% CsA ophthalmic formulation followed by Restasis 0.05% CsA ophthalmic formulation |
|
| Arm II | Experimental | Restasis 0.05% CsA ophthalmic formulation followed by Oph1 0.5% CsA ophthalmic formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oph1 | Drug | 0.5% CsA ophthalmic formulation, twice daily for 4 days and once on the fifth day, one eye (right). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drop Discomfort VAS score | Eye Discomfort VAS scale from 0-100 | up to Fifth day per treatment (last dose for each treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Drop Comfort VAS score | Eye Discomfort VAS scale from 0-100 | 1-minute post-Dose. Fifth day per treatment (last dose for each treatment) |
| Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Double blinded, participant and Outcome Assessors are blinded to the intervention
| Restasis | Drug | 0.05% CsA ophthalmic formulation twice daily for 4 days and once on the fifth day, one eye (right). |
|
Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100
| 1 minutes post-Dose instillation, Day 1-5, Day 8-12, AM |
| Drop Discomfort Detailed VAS score. Calculated mean of all scores per treatment for each of the VAS scale. | Eye Discomfort, Itching, Burning, Foreign body feel VAS scales from 0-100 | 5 minutes post-Dose instillation, Day 1-5, Day 8-12, AM |
| D000602 |
| Amino Acids, Peptides, and Proteins |