Approval Probability
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Adjusted LOA
ML Risk
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...
Hyaluronate, 0.18% is an ophthalmic solution used for the treatment of Dry Eye Syndrome. It is a small molecule therapy being developed by Alcon Inc. for this condition. The drug is currently in Phase 3 clinical development.
Hyaluronate, 0.18% is being developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate this ophthalmic solution for the treatment of Dry Eye Syndrome.
Hyaluronate, 0.18% is in Phase 3 clinical development for Dry Eye Syndrome. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed to assess its safety and efficacy.
Hyaluronate, 0.18% has one completed Phase 3 clinical trial with the identifier NCT01382225. This trial, titled 'Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome,' enrolled 1,936 participants and was a randomized, double-blind, placebo-controlled study.
Yes, Hyaluronate, 0.18% is also known as sodium hyaluronate ophthalmic solution. The clinical trial NCT01382225 refers to it as 'Sodium Hyaluronate Ophthalmic Solution, 0.18%,' confirming that these names refer to the same drug being studied for Dry Eye Syndrome.