TTAX03 for Dry Eye Syndrome

Recruiting at 3 trial locations

Overseen By VP Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioTissue Holdings, Inc

Must not be taking: Nasal cholinergics, Glaucoma meds

Disqualifiers: Corneal ectatic disorder, Severe blepharitis, Severe conjunctivochalasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 5 days

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED. The primary question it aims to answer is if TTAX03 is safe. The secondary is the effectiveness. Researchers will compare 10mg of TTAX03 reconstituted in 150, 300, or 600 uL saline to the saline control group to look at effectiveness. Participants will be randomized to a treatment group one time and be evaluated at 5 different study visits.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using a nasal cholinergic agonist or topical glaucoma medication, you may need to stop as these are listed in the exclusion criteria.

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate dry eye disease (DED). Participants should not have any other serious eye conditions or infections. They must be willing to attend five study visits.

Inclusion Criteria

I can attend all required study visits and procedures.

My eye has moderate to severe dryness based on a specific test.

In the opinion of the investigator, the participant can follow oral and written instructions

Exclusion Criteria

I have nerve pain in my eye.

I have used a nasal spray like Tyrvaya in the last month.

My eye appears sunken because of lost eye socket fat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTAX03 or saline control via bandage contact lens for 5 days

5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

4 visits (in-person) at Day 6, Day 29, Day 57, and Day 85

What Are the Treatments Tested in This Trial?

Interventions

• TTAX03

Trial Overview The study tests the safety and effectiveness of TTAX03 compared to saline, which serves as a placebo. Participants will receive one dose of TTAX03 in varying volumes of saline and their responses will be evaluated over time.

How Is the Trial Designed?

Group I: 10mg TTAX03 reconstituted in 150 uL saline Experimental Treatment 1 Intervention

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Group II: 10mg TTAX03 reconstituted in 300 uL saline Active Control 1 Intervention

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Group III: 10mg TTAX03 reconstituted in 600 uL saline Active Control 1 Intervention

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Group IV: 300 uL of saline Placebo Group 1 Intervention

For all four groups, 100 mL of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the study eye.

Who Is Running the Clinical Trial?

BioTissue Holdings, Inc

Lead Sponsor

Trials

17

Recruited

970+