Dry EyePhase 2NCT06780306
A Study in the Treatment of Mild to Moderate Dry Eye Disease Comparing Saline to TTAX03.
A Phase 2 study testing TTAX03 in people with Dry Eye and Dry Eye Disease (DED), run by BioTissue Holdings, Inc at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Disease (DED), Dry Eye Disease With Severe Keratitis
- What is being tested?
- TTAX03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Dec 2024to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Provision of signed and dated informed consent form.
- Baseline VAS Dryness score ≥40
- Baseline Ocular Surface Disease Index (OSDI) score ≥ 13.
- Baseline corneal fluorescein staining with a total score ≥ 4 but ≤13, and ≥ 2 in at least one region, by the NEI Grading System† in the study eye.
- In the opinion of the investigator, the participant can follow oral and written instructions.
- In the opinion of the investigator, the participant can complete all study procedures and visits.
Who cannot join
- Has a corneal ectatic disorder or other ocular surface disease such as limbal stem cell deficiency or a cicatricial component (e.g., symblepharon, fornix foreshortening and lid margin/lashes abnormality) caused for example by oGVHD, irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermal necrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival goblet cells (as with vitamin A deficiency).
- Has severe blepharitis or severe obvious inflammation of the lid margin.
- Has severe conjunctivochalasis.
- Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid.
- Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) or history of recurrent corneal erosion
- Has neuropathic corneal pain
Show all 24Show fewer
- Has a sunken globe (due to the reduction or loss of orbital fat)
- Has severe DED per corneal fluorescein staining with a total score ≥ 13by the NEI Grading System in either eye.
- Prior history of intolerance or adverse events using BCL.
- Have had dissolvable or temporary plug(s) (including hydrogel or Lacrifill®) inserted within 6 months prior to screening.
- Is using a nasal cholinergic agonist such as Tyrvaya in the last 30 days.
- Has had previous ocular surgery in the study eye within the past 12 weeks.
- Plans to use autologous serum drops during the study period in either eye.
- Has elevated intraocular pressure >21mmHg in either eye requiring topical therapy.
- Is currently using or plans to use topical glaucoma medication in either eye.
- Has a known allergy to topical ophthalmic sodium fluorescein dye.
- Has a known intolerance to unbuffered normal saline.
- Prior adverse events of using human birth tissue product.
- Is currently incarcerated or anticipates possible incarceration during the time course of this study.
- Has tested positive for COVID-19 within 28 days prior to screening.
- Is currently participating in any other type of eye-related clinical or research study that in the opinion of the investigator would confound or would risk confounding study results.
- Has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound study outcomes, or may significantly interfere with the participant's participation in the study.
- Prior amniotic membrane product used for dry eye therapy in the study eye in the past 6 months.
- Has Strabismus (squint/crossed eyes) or Amblyopia (lazy eye).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Westlake Eye Specialists
Austin, Texas, 78749
University California Berkeley
Berkeley, California, 94720
Southwest Eye Care
Chaska, Minnesota, 55318
Advanced Research, LLC.
Deerfield Beach, Florida, 33064
Eye Associates of North Jersey
Dover, New Jersey, 07801
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Wilmington Eye at Brunswick Forest
Leland, North Carolina, 28451
CORE, Inc. / Vita Eye Clinic
Shelby, North Carolina, 28150
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
About this study
Official title: A Phase 2 Randomized, Controlled, Multicenter, Dose Optimization Study of TTAX03 in the Treatment of Mild to Moderate Dry Eye Disease (DED)
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.
Read the detailed description
The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED. After confirmation of inclusion and exclusion criteria, all eligible patients will be randomized in a 1:1:1:1 ratio to receive one of the three doses of TTAX03 (10 mg of TTAX03 reconstituted in 150, 300, or 600 uL saline, i.e., subgroup A, B, and C, respectively) or to the saline control group (subgroup D). For all four groups, the same volume of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the eye. The more severe eye will serve as the study eye, which meets inclusion and exclusion criteria. The treatment period is 5 days of continuous bandage contact lens wear. Safety follow-up without further treatment will continue for twelve weeks. After baseline (day 1) and completion of treatment, enrolled patients will be evaluated for safety and efficacy at Day 6 ± 1, Day 29 ± 3, Day 57 ± 3, and Day 85 ± 3.
- Being tested
- TTAX03, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTAX03Biological
Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord
Saline (NaCl 0,9 %) (placebo)Biological
300 mL Sterile, preservative free 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| 10mg TTAX03 reconstituted in 150 uL saline | Experimental | 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. Receives: Biological: TTAX03 |
| 10mg TTAX03 reconstituted in 300 uL saline | Active comparator | 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. Receives: Biological: TTAX03 |
| 10mg TTAX03 reconstituted in 600 uL saline | Active comparator | 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. Receives: Biological: TTAX03 |
| 300 uL of saline | Placebo comparator | 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. Receives: Biological: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine 12 week ocular and general safety after application of TTAX03.
Incidence and nature of treatment emergent adverse events (TEAE) between TTAX03 and saline.
Measured: 12 weeks
Secondary outcomes (24)
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 6 by group.
Determine the relationship between TTAX03 doses and efficacy per changes from baseline in complete resolution of superficial punctate keratopathy (defined by corneal fluorescein staining) at Day 6 when compared to the saline control.
Measured: Day 6
Mean change from baseline to Day 6 in corneal fluorescein staining (National Eye Institute (NEI) score) by group.
Examine the relationship between TTAX03 doses and changes from baseline in corneal epithelial staining at Day 6 when compared to the saline control.
Measured: Baseline to Day 6
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 6 by group.
Examine the relationship between TTAX03 doses and clinically meaningful changes from baseline vs. saline in corneal staining during the follow up to 12 weeks.
Measured: Baseline to Day 6
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 29 by group.
Examine the relationship between TTAX03 doses and clinically meaningful changes from baseline vs. saline in corneal staining during the follow up to 12 weeks.
Measured: Baseline to Day 29
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 57 by group.
Examine the relationship between TTAX03 doses and clinically meaningful changes from baseline vs. saline in corneal staining during the follow up to 12 weeks.
Measured: Baseline to Day 57
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 85 by group.
Examine the relationship between TTAX03 doses and clinically meaningful changes from baseline vs. saline in corneal staining during the follow up to 12 weeks.
Measured: Baseline to Day 85
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 6 by group.
Examine the relationship between TTAX03 doses and change of dry eye symptoms from baseline when compared to saline at Day 6.
Measured: Baseline to Day 6
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 6 by group.
Examine the relationship between TTAX03 doses and change of dry eye symptoms from baseline when compared to saline at Day 6.
Measured: Baseline to Day 6
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 6 by group.
Examine the relationship between TTAX03 doses and change of best corrected visual acuity (BCVA) from baseline when compared to saline at Day 6.
Measured: Baseline to Day 6
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 29 by group.
Examine the relationship between TTAX03 doses and percentages of participants showing complete resolution of corneal staining from baseline when compared to saline during the follow up 12 weeks.
Measured: Day 29
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 57 by group.
Examine the relationship between TTAX03 doses and percentages of participants showing complete resolution of corneal staining from baseline when compared to saline during the follow up 12 weeks.
Measured: Day 57
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 85 by group.
Examine the relationship between TTAX03 doses and percentages of participants showing complete resolution of corneal staining from baseline when compared to saline during the follow up 12 weeks.
Measured: Day 85
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 29 by group.
Examine the relationship between TTAX03 doses and change of corneal epithelial staining from baseline between when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 29
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 57 by group.
Examine the relationship between TTAX03 doses and change of corneal epithelial staining from baseline between when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Baseline to Day 57
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 85 by group.
Examine the relationship between TTAX03 doses and change of corneal epithelial staining from baseline between when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Baseline to Day 85
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 29 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 29
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 57 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 57
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 85 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 85
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 29 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 29
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 57 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 57
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 85 by group.
Examine the relationship between TTAX03 doses and change of ocular dry eye symptoms from baseline when compared to saline during the follow up to 12 weeks.
Measured: Baseline to Day 85
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Days 29 by group.
Examine the relationship between TTAX03 doses and change of BCVA from baseline when compared to saline during the follow up to 12 weeks.
Measured: Day 29
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 57 by group.
Examine the relationship between TTAX03 doses and change of BCVA from baseline when compared to saline during the follow up to 12 weeks.
Measured: Day 57
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 85 by group.
Examine the relationship between TTAX03 doses and change of BCVA from baseline when compared to saline during the follow up to 12 weeks.
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start12 Dec 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780306
- Sponsor's protocol ID
- TTAX03-CR010
- Status last verified
- Sep 2025
- First submitted
- 13 Jan 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Controlled, Multicenter, Dose Optimization Study of TTAX03 in the Treatment of Mild to Moderate Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT06780306
- Acronym / sponsor ID
- TTAX03-CR010
- Keywords
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this randomized, controlled, multicenter study is to evaluate the safety and efficacy of TTAX03 in participants with mild to moderate DED. After confirmation of inclusion and exclusion criteria, all eligible patients will be randomized in a 1:1:1:1 ratio to receive one of the three doses of TTAX03 (10 mg of TTAX03 reconstituted in 150, 300, or 600 uL saline, i.e., subgroup A, B, and C, respectively) or to the saline control group (subgroup D). For all four groups, the same volume of reconstituted solution will be applied into the concave bowl of a bandage contact lens and inserted into the eye. The more severe eye will serve as the study eye, which meets inclusion and exclusion criteria. The treatment period is 5 days of continuous bandage contact lens wear. Safety follow-up without further treatment will continue for twelve weeks. After baseline (day 1) and completion of treatment, enrolled patients will be evaluated for safety and efficacy at Day 6 ± 1, Day 29 ± 3, Day 57 ± 3, and Day 85 ± 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10mg TTAX03 reconstituted in 150 uL saline | Experimental | Biological: TTAX03For 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. |
| 10mg TTAX03 reconstituted in 300 uL saline | Active comparator | Biological: TTAX03For 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. |
| 10mg TTAX03 reconstituted in 600 uL saline | Active comparator | Biological: TTAX03For 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. |
| 300 uL of saline | Placebo comparator | Biological: Saline (NaCl 0,9 %) (placebo)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old.
- Provision of signed and dated informed consent form.
- Baseline VAS Dryness score ≥40
- Baseline Ocular Surface Disease Index (OSDI) score ≥ 13.
- Baseline corneal fluorescein staining with a total score ≥ 4 but ≤13, and ≥ 2 in at least one region, by the NEI Grading System† in the study eye.
Key exclusion criteria (24 listed)
- Has a corneal ectatic disorder or other ocular surface disease such as limbal stem cell deficiency or a cicatricial component (e.g., symblepharon, fornix foreshortening and lid margin/lashes abnormality) caused for example by oGVHD, irradiation, chemical burns, trachoma, Stevens Johnson syndrome/toxic epidermal necrolysis, ocular cicatricial pemphigoid, or the destruction of conjunctival goblet cells (as with vitamin A deficiency).
- Has severe blepharitis or severe obvious inflammation of the lid margin.
- Has severe conjunctivochalasis.
- Has nocturnal exposure e.g. incomplete closure or lagophthalmos or floppy eyelid.
- Has epithelial basement membrane dystrophy (i.e., map-dot-fingerprint dystrophy) or history of recurrent corneal erosion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTAX03Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord | Biological | 10mg TTAX03 reconstituted in 150 uL saline, 10mg TTAX03 reconstituted in 300 uL saline, 10mg TTAX03 reconstituted in 600 uL saline |
| Saline (NaCl 0,9 %) (placebo)300 mL Sterile, preservative free 0.9% NaCl | Biological | 300 uL of saline |
Primary outcome
Determine 12 week ocular and general safety after application of TTAX03.
Time frame: 12 weeks
Incidence and nature of treatment emergent adverse events (TEAE) between TTAX03 and saline.
24 secondary outcomes
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 6 by group.
Time frame: Day 6
Mean change from baseline to Day 6 in corneal fluorescein staining (National Eye Institute (NEI) score) by group.
Time frame: Baseline to Day 6
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 6 by group.
Time frame: Baseline to Day 6
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 29 by group.
Time frame: Baseline to Day 29
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 57 by group.
Time frame: Baseline to Day 57
Proportion of participants with clinically meaningful reduction in corneal fluorescein staining (NEI ≥ 3) from baseline to Day 85 by group.
Time frame: Baseline to Day 85
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 6 by group.
Time frame: Baseline to Day 6
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 6 by group.
Time frame: Baseline to Day 6
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 6 by group.
Time frame: Baseline to Day 6
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 29 by group.
Time frame: Day 29
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 57 by group.
Time frame: Day 57
Proportion of participants who show complete resolution of superficial punctate keratopathy, i.e., absence of corneal fluorescein staining, on Day 85 by group.
Time frame: Day 85
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 29 by group.
Time frame: Baseline to Day 29
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 57 by group.
Time frame: Baseline to Baseline to Day 57
Mean change from baseline in corneal fluorescein staining (National Eye Institute (NEI) score) on Day 85 by group.
Time frame: Baseline to Baseline to Day 85
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 29 by group.
Time frame: Baseline to Day 29
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 57 by group.
Time frame: Baseline to Day 57
Mean change in dry eye symptoms (measured by OSDI) from baseline on Day 85 by group.
Time frame: Baseline to Day 85
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 29 by group.
Time frame: Baseline to Day 29
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 57 by group.
Time frame: Baseline to Day 57
Mean change in dry eye symptoms (measured by VAS) from baseline on Day 85 by group.
Time frame: Baseline to Day 85
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Days 29 by group.
Time frame: Day 29
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 57 by group.
Time frame: Day 57
Mean change from baseline in BCVA (logMAR) measured by ETDRS chart on Day 85 by group.
Time frame: Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTAX03 in people with Dry Eye and Dry Eye Disease (DED), run by BioTissue Holdings, Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine 12 week ocular and general safety after application of TTAX03. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.