TTAX03 for Dry Eye Syndrome

Recruiting at 9 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?

This trial tests a new treatment called TTAX03 to determine its safety and effectiveness for people with mild to moderate dry eye syndrome. Participants will receive either TTAX03 in varying amounts of saline or just saline for comparison. The study aims to determine if TTAX03 can relieve dry eye discomfort. Ideal candidates are those who have experienced noticeable dry eyes for some time, with symptoms affecting their daily lives. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that TTAX03 is likely to be safe for humans?

Research shows that TTAX03 is being tested for safety in treating dry eye syndrome. This condition occurs when eyes don't produce enough tears or the right kind, causing itchiness, dryness, or a sensation of something in the eye.

Currently, little information exists on the safety of TTAX03. However, the study's early stage suggests that earlier tests showed some promise. In early studies like this one, the main focus is to determine if the treatment is safe for people.

Reaching this stage usually indicates that earlier tests didn't reveal major safety issues. This study will help researchers learn more about how well people tolerate TTAX03. Participants in this trial will provide the information needed to ensure TTAX03 is safe for treating dry eye syndrome. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dry eye syndrome?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears or anti-inflammatory medications, TTAX03 is administered directly to the eye using a bandage contact lens. This unique delivery method allows for a more sustained release of the medication, potentially increasing its effectiveness and comfort for the patient. Additionally, TTAX03 is being tested in varying concentrations, offering the possibility of customizing treatment to better suit individual needs. Researchers are excited about TTAX03 because it could provide faster and more efficient relief for those suffering from dry eye symptoms.

What evidence suggests that TTAX03 might be an effective treatment for dry eye syndrome?

Research shows that TTAX03 might help ease symptoms of dry eye syndrome (DED). Dry eye syndrome occurs when eyes don't produce enough tears or the right kind of tears. This trial tests TTAX03 in different formulations to reduce inflammation, a cause of dry eye symptoms. Previous studies have shown that treatments reducing inflammation can alleviate symptoms like redness and irritation. Although limited human data exists on TTAX03, it functions similarly to other successful dry eye treatments, suggesting that TTAX03 could potentially relieve dry eye symptoms. ^{1 4 6 7 8}

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 used a nasal spray like Tyrvaya in the last month.

I have nerve pain in my eye.

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06780306

A Study in the Treatment of Mild to Moderate Dry Eye ... The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06780306/a-study-in-the-treatment-of-mild-to-moderate-dry-eye-disease-comparing-saline-to-ttax03

A Study in the Treatment of Mild to Moderate Dry Eye ... Researchers will compare 10mg of TTAX03 reconstituted in 150, 300, or 600 uL saline to the saline control group to look at effectiveness.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35608780/

Selective Pharmacologic Therapies for Dry Eye Disease ... Several anti-inflammatory, topical ophthalmic therapies are available to treat clinical signs and symptoms of DED in the USA and Europe.

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0074986

Dry Eye Syndrome (DES) (DBCOND0074986) Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. No drug interventions, treatment, 1, completed.

5. malacards.org malacards.org/card/keratoconjunctivitis_sicca

Keratoconjunctivitis Sicca (KCS) The condition can result in blurred vision, tear film instability, increased risk of ocular surface damage like corneal scarring, and changes in the eye's ...

6. withpower.com withpower.com/trial/ttax03-for-dry-eye-syndrome-80034

TTAX03 for Dry Eye Syndrome 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 ...

7. clinconnect.io clinconnect.io/trials/NCT05481450

Efficacy and Safety Safety of Nutritears® in Adults With Dry eye syndrome (DES) affects a significant population around the world. Tear film moistens and prevents the ocular surface from dust, toxins, pollutants, etc.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282798/

Efficacy and safety of perfluorohexyloctane (PFHO) in patients ... It has proved to be highly effective in alleviating eye dryness and associated symptoms. While minor side effects are seen in a small subset of ...