Trial · NCT01751126

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

NCT01751126, Phase 3, Completed, Santen SAS; results first posted 2022-03-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis. Trials, record NCT01751126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01751126

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
NCT number: NCT01751126
Status: Completed
Phases: Phase 3
Enrollment: 169 participants, actual
Lead sponsor: Santen SAS
Conditions: Vernal Keratoconjunctivitis
Interventions: NOVA22007 ''Ciclosporin'', Placebo
First posted: 2012-12-17
Last updated: 2022-03-28
Results first posted: 2022-03-28

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months	over the 4 months	Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS.
Secondary	Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	Up to Month4	Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision.
Secondary	Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II	Up to Month12	Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision.
Secondary	Number of Courses of Rescue Medication in Period I	Up to Month4	Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months	over the 4 months		Penalties Adjusted CFS Score	MEAN
SECONDARY	Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	Up to Month4	SS population	letters	MEAN
SECONDARY	Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II	Up to Month12	SS population	letters	MEAN
SECONDARY	Number of Courses of Rescue Medication in Period I	Up to Month4	Participants reduced due to missing data	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group120

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months	High Dose Regimen		2.06	Standard Deviation 1.44	Penalties Adjusted CFS Score
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months	Low Dose Regimen		1.93	Standard Deviation 1.37	Penalties Adjusted CFS Score
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months	Placebo		1.34	Standard Deviation 1.22	Penalties Adjusted CFS Score
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	LogMAR - High Dose Regimen	Analysis Eye-Baseline	0.293	Standard Deviation 0.297	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	LogMAR - Low Dose Regimen	Analysis Eye-Baseline	0.209	Standard Deviation 0.284	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	LogMAR-Placebo	Analysis Eye-Baseline	0.302	Standard Deviation 0.347	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	Change From Baseline in LogMAR- High Dose	Analysis Eye-Baseline	0	Standard Deviation 0	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	Change From Baseline in LogMAR- Low Dose	Analysis Eye-Baseline	0	Standard Deviation 0	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	Change From Baseline in LogMAR- Placebo	Analysis Eye-Baseline	0	Standard Deviation 0	letters
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I	LogMAR - High Dose Regimen	Analysis Eye-Month 1	0.263	Standard Deviation 0.292	letters

1 to 10 of 120Source ClinicalTrials.gov

See all 120 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period I	STARTED	High Dose Regimen	57
Period I	STARTED	Low Dose Regimen	54
Period I	STARTED	Placebo	58
Period I	COMPLETED	High Dose Regimen	51
Period I	COMPLETED	Low Dose Regimen	43
Period I	COMPLETED	Placebo	49
Period I	NOT COMPLETED	High Dose Regimen	6
Period I	NOT COMPLETED	Low Dose Regimen	11
Period I	NOT COMPLETED	Placebo	9
Period II	STARTED	High Dose Regimen	72

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events546

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
other	Ocular hyperaemia	Eye disorders	.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	2	50
other	Ocular hyperaemia	Eye disorders	Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	2	22
other	Ocular hyperaemia	Eye disorders	Total High Dose	4	72
other	Ocular hyperaemia	Eye disorders	.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)	0	44
other	Ocular hyperaemia	Eye disorders	Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)	1	26
other	Ocular hyperaemia	Eye disorders	Total Low Dose	1	70
other	Eye pruritus	Eye disorders	.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	0	50
other	Eye pruritus	Eye disorders	Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	3	22
other	Eye pruritus	Eye disorders	Total High Dose	3	72
other	Eye pruritus	Eye disorders	.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)	0	44

1 to 10 of 546Source ClinicalTrials.gov

See all 546 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
Total, all-cause mortality	Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)
Total, all-cause mortality	Total High Dose
Total, all-cause mortality	.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
Total, all-cause mortality	Vehicle QID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)
Total, all-cause mortality	Total Low Dose
Total, other adverse events	.1% QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	29	50
Total, other adverse events	Vehicle QID (4 Months) Plus .1% QID (8 Months Safety Follow-up)	13	22
Total, other adverse events	Total High Dose	42	72
Total, other adverse events	.1% BID + Vehicle BID (4 Months) Plus .1% BID+ Vehicle BID (8 Months Safety Follow-up)	24	44

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

GET https://conductscience.org/api/trials/v1/NCT01751126

GET https://conductscience.org/api/trials/v1/NCT01751126/results?page=2

API reference For AI assistants