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Also known as Sodium Hyaluronate Ophthalmic Solution, 0.18%
Hyaluronate, 0.18% · 1 trial · 1 indication
The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=\>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.
The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.
| Arm | Type | Description |
|---|---|---|
| Sodium Hyaluronate | EXPERIMENTAL | Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| Vehicle | PLACEBO_COMPARATOR | Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days |
| Name | Type | Description |
|---|---|---|
| Sodium Hyaluronate Ophthalmic Solution, 0.18% | DRUG | - |
| Vehicle | OTHER | Inactive ingredients used as run-in and placebo comparator |
Inclusion Criteria: * Documented history of dry eyes for at least 3 months. * Ocular discomfort due to dry eyes. * Presence of corneal and conjunctival staining. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Women who are pregnant or lactating. * Contact lens wear w...
Top 2 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
Hyaluronate, 0.18% is an ophthalmic solution being developed for the treatment of Dry Eye Syndrome. It is formulated as a 0.18% concentration for topical use in the eye and is designed for adults 18 years and older. It is not currently approved and remains in clinical development.
Hyaluronate, 0.18% is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor of the clinical program evaluating this ophthalmic solution for Dry Eye Syndrome.
Hyaluronate, 0.18% has completed a Phase 3 clinical trial. It is an investigational product and is not approved for commercial use. The Phase 3 study has finished, and no trials are currently listed as active.
Hyaluronate, 0.18% was evaluated in one Phase 3 trial, NCT01382225, titled Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome. The study enrolled 1,936 participants, was randomized, double-blind, and placebo-controlled, and has completed.
Yes. Hyaluronate, 0.18% is also known as Sodium Hyaluronate Ophthalmic Solution, 0.18%. The two names refer to the same investigational ophthalmic product developed by Alcon Inc. for Dry Eye Syndrome.
The Phase 3 trial NCT01382225 was a randomized, double-blind, placebo-controlled study of Hyaluronate, 0.18% in Dry Eye Syndrome. It enrolled 1,936 participants aged 18 years and older of all sexes and did not use biomarker selection. The trial has completed.