Trial · Interventional
CompletedPhase 2Results postedRegistry data1 trial · 1 completed · 1 with posted results
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
NCT01387347Aug 2011 to Dec 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye.
Active comparator
Thymosin Beta 4
RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4
Placebo comparator
Placebo
The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Outcomes the sponsor listed as primary.
Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye
Time frame · Day 29 (end of treatment)
This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect). Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye.
Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.
Time frame · Day 29 (end of treatment)
Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort. If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye.
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame · Throughout the study till Day 29
The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Thymosin Beta 4 | 2.08 | 0.71 |
| Placebo | 1.9 | 0.63 |
| Group | Value (Units on a Scale) | Spread |
|---|---|---|
| Placebo | 1.3 | 1.1 |
| Thymosin Beta 4 | 1.6 | 1.2 |
| Group | Value (Events) |
|---|---|
| Placebo | 2 |
| Thymosin Beta 4 | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboThe placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor. Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days. | – | 0 / 36 | 2 / 36 |
| Thymosin Beta 4RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days. | – | 0 / 36 | 0 / 36 |
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