Trial · NCT04037891
Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
NCT04037891, Phase 1, Phase 2, Terminated, AKARI Therapeutics; results first posted 2025-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical rVA576 for Treatment of Atopic Keratoconjunctivitis. Trials, record NCT04037891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04037891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical rVA576 for Treatment of Atopic Keratoconjunctivitis
- NCT number
- NCT04037891
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- AKARI Therapeutics
- Conditions
- Keratoconjunctivitis, Atopic, Keratoconjunctivitis, Vernal, Conjunctivitis, Allergic
- Interventions
- rVA576, Placebo, rVA576
- First posted
- 2019-07-30
- Last updated
- 2025-04-10
- Results first posted
- 2025-02-27
- Limitations and caveats
1. Early termination due to the Covid-19 pandemic.~2. Uneven distribution of patients between rVA576 and placebo in Part 2, due to incorrect storage and impossibility of manufacturing a new batch, leading to replacement by the only available randomized and labelled product and resulting in patients being allocated to placebo. With a 6 to 3 distribution of completed patients it is difficult to draw meaningful statistical conclusions or detect trends. The safety data were not compromised.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Ocular TEAE | 56 days | Incidence of ocular treatment-emergent adverse events (TEAE) during the treatment period which have occurred during the 56 days following randomisation. |
| Secondary | Post-instillation Comfort | Day 1 to 56 | Graded on patient diary cards at the intervals Day 1-14, 15-28, 29-42 and 43-56. Eye comfort scoring: 0 - Perfectly comfortable 1. \- Slight discomfort. Some burning, itching or stinging for up to half a minute after using the eye drop, solution but the discomfort improves without treatment. 2. \- Moderate discomfort. Burning, itching or stinging lasts for 0.5 minute or longer but improves without treatment. 3. \- Severe discomfort. Burning, itching or stinging last for at least 0.5 minute and requires washing the eyes to relieve it. 4. \- Unbearable burning itching or stinging. So severe that you cannot continue treatment. The 14 day average score for each interval have been calculated for each patient (possible range of 0 to 40). Classifications were assigned using the average total score at each two week period as follows: \< 10 = Comfortable/Acceptable, 10 - 19 = Moderately Uncomfortable, 20 - 29 = Very Uncomfortable, \>= 30 = Severely/Unacceptably Uncomfortable. |
| Secondary | Visual Acuity | Day 1 to 56 | Visual acuity for the worst eye over time by Early Treatment Diabetic Retinopathy Study (ETDRS) charts comparison from Day 1 to Day 56 In ETDRS charts, zero indicates standard vision, positive values indicates poor vision, and negative values indicates good vision. |
| Secondary | Clinical Scores | Day 1 to 56 | Change from Day 1 in composite clinical scores at Day 14, 28, 42 and 56, for the eye judged as worst affected at each visit. Score calculated from symptom and sign sub-components. AKC/VKC: symptom sub-component consisted of itch, tearing, discomfort, discharge, and photophobia, and the sign component consisted of bulbar conjunctival hyperaemia, tarsal conjunctival papillary hypertrophy, punctate keratitis, neovascularization of cornea, cicatrizing conjunctivitis, blepharitis. SAC/PAC: symptom sub-component consisted itch, tearing, discomfort, and photophobia, and the sign sub-component consisted of upper tarsal conjunctival hyperaemia, upper bulbar conjunctival hyperaemia, chemosis, upper tarsal conjunctival papillae, blepharitis. For each sign/symptom a score of 0 - 3 is awarded (0=absence of a sign/symptom; an increase in score indicates increase in severity). These scores are summed at the end of the exam to give the composite score. Range:0 to 33 (AKC/VKC) or 27 (SAC/PAC). |
| Secondary | MMP-9 Positive | Day 1 to 56 | Percentage of patients with Matrix metalloprotease 9 (MMP-9) positive levels at Days 1, 28, and 56. MMP-9 is a is a nonspecific inflammatory marker. Detection was made using the Inflammadry® device. This device gives a binary (positive/negative) result. |
| Secondary | Tear Film Break up Time | Change from Day 1 at Day 14, 28, 42 and 56 | Change from Day 1 in Tear film break up time (TBUT) at Day 14, 28, 42 and 56. TBUT data was available for one eye only. Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. A TBUT under 10 seconds is considered abnormal. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Ocular TEAE | 56 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Post-instillation Comfort | Day 1 to 56 | The Comfort score data was not available for one patient in the nomacopan group Part 2, and in one patient in Part 1, after Day 14, both due to withdrawal.~Because only two patients in the Part 2 nomacopan group had data to assess comfort score, it is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Visual Acuity | Day 1 to 56 | Only one patient in the nomacopan group in Part 2 had data to assess this score. It is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed. | Number of ETDRS letters | MEAN |
| SECONDARY | Clinical Scores | Day 1 to 56 | Because only two patients in the Part 2 nomacopan group had data to assess this score, it is not meaningful to compare the nomacopan and placebo groups, and so further analysis was not performed.~Note there were two patients on Placebo with SAC; therefore, scored on a different scale compared to patients with AKC or VKC. For the purposes of the outcome measure, the SAC and AKC/VKC scores were combined to derive a single value across all participants. | score on a scale | MEAN |
| SECONDARY | MMP-9 Positive | Day 1 to 56 | There were too few patients to make a meaningful interpretation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Tear Film Break up Time | Change from Day 1 at Day 14, 28, 42 and 56 | Patient numbers within each treatment group are too small to make meaningful comparisons, and so no further analysis was performed. | seconds | MEAN |
Source ClinicalTrials.gov
Results by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Ocular TEAE | rVA576, Open-label Period | 3 | Participants | ||
| Incidence of Ocular TEAE | rVA576, Double-blind Period | 2 | Participants | ||
| Incidence of Ocular TEAE | Placebo | 3 | Participants | ||
| Post-instillation Comfort | rVA576, Open-label Period | Day 1 to 14 / Comfortable/Acceptable | 3 | Participants | |
| Post-instillation Comfort | rVA576, Double-blind Period | Day 1 to 14 / Comfortable/Acceptable | 1 | Participants | |
| Post-instillation Comfort | Placebo | Day 1 to 14 / Comfortable/Acceptable | 4 | Participants | |
| Post-instillation Comfort | rVA576, Open-label Period | Day 1 to 14 / Moderately Uncomfortable | 0 | Participants | |
| Post-instillation Comfort | rVA576, Double-blind Period | Day 1 to 14 / Moderately Uncomfortable | 1 | Participants | |
| Post-instillation Comfort | Placebo | Day 1 to 14 / Moderately Uncomfortable | 2 | Participants | |
| Post-instillation Comfort | rVA576, Open-label Period | Days 15 to 28 / Comfortable/Acceptable | 2 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period | STARTED | rVA576, Open-label Period (8 Weeks) | 3 | |
| Open-label Period | STARTED | rVA576, Double-blind Period (8 Weeks) | 0 | |
| Open-label Period | STARTED | Placebo (8 Weeks) | 0 | |
| Open-label Period | COMPLETED | rVA576, Open-label Period (8 Weeks) | 2 | |
| Open-label Period | COMPLETED | rVA576, Double-blind Period (8 Weeks) | 0 | |
| Open-label Period | COMPLETED | Placebo (8 Weeks) | 0 | |
| Open-label Period | NOT COMPLETED | rVA576, Open-label Period (8 Weeks) | 1 | |
| Open-label Period | NOT COMPLETED | rVA576, Double-blind Period (8 Weeks) | 0 | |
| Open-label Period | NOT COMPLETED | Placebo (8 Weeks) | 0 | |
| Randomized, Double-blind Period | STARTED | rVA576, Open-label Period (8 Weeks) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atopic keratoconjunctivitis | Eye disorders | rVA576, Open-label Period | 1 | 3 | 1 |
| other | Atopic keratoconjunctivitis | Eye disorders | rVA576, Double-blind Period | 1 | 3 | 2 |
| other | Atopic keratoconjunctivitis | Eye disorders | Placebo | 0 | 6 | 0 |
| other | Keratitis | Eye disorders | rVA576, Open-label Period | 0 | 3 | 0 |
| other | Keratitis | Eye disorders | rVA576, Double-blind Period | 1 | 3 | 1 |
| other | Keratitis | Eye disorders | Placebo | 1 | 6 | 1 |
| other | Ocular hyperaemia | Eye disorders | rVA576, Open-label Period | 2 | 3 | 2 |
| other | Ocular hyperaemia | Eye disorders | rVA576, Double-blind Period | 0 | 3 | 0 |
| other | Ocular hyperaemia | Eye disorders | Placebo | 0 | 6 | 0 |
| other | Conjunctival hyperaemia | Eye disorders | rVA576, Open-label Period | 0 | 3 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rVA576, Open-label Period | 0 | 3 |
| Total, all-cause mortality | rVA576, Double-blind Period | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | rVA576, Open-label Period | 3 | 3 |
| Total, other adverse events | rVA576, Double-blind Period | 2 | 3 |
| Total, other adverse events | Placebo | 3 | 6 |
| Total, serious adverse events | rVA576, Open-label Period | 0 | 3 |
| Total, serious adverse events | rVA576, Double-blind Period | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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