Trial · NCT03292809

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

NCT03292809, Phase 2, Phase 3, Completed, Novaliq GmbH; results first posted 2021-05-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED). Trials, record NCT03292809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292809

On this page

Trial

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

Title: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
NCT number: NCT03292809
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 328 participants, actual
Lead sponsor: Novaliq GmbH
Conditions: Dry Eye Disease
Interventions: CyclASol topical ocular, eye drops, Vehicle topical ocular, eye drops
First posted: 2017-09-26
Last updated: 2022-12-22
Results first posted: 2021-05-21

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Corneal Fluorescein Staining at Day 29	baseline and 1 month [day 29]	CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Primary	Change From Baseline in Ocular Surface Disease Index at Day 29	baseline and 1 month [day 29]	The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Corneal Fluorescein Staining at Day 29	baseline and 1 month [day 29]		score on a scale	MEAN
PRIMARY	Change From Baseline in Ocular Surface Disease Index at Day 29	baseline and 1 month [day 29]		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Total Corneal Fluorescein Staining at Day 29	CyclASol Ophthalmic Solution	-2.9	Standard Deviation 2.59	score on a scale
Change From Baseline in Total Corneal Fluorescein Staining at Day 29	Vehicle Ophthalmic Solution	-2.2	Standard Deviation 2.73	score on a scale
Change From Baseline in Ocular Surface Disease Index at Day 29	CyclASol Ophthalmic Solution	-7.08	Standard Deviation 18.650	score on a scale
Change From Baseline in Ocular Surface Disease Index at Day 29	Vehicle Ophthalmic Solution	-5.37	Standard Deviation 15.291	score on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CyclASol Ophthalmic Solution	162
Overall Study	STARTED	Vehicle Ophthalmic Solution	166
Overall Study	COMPLETED	CyclASol Ophthalmic Solution	155
Overall Study	COMPLETED	Vehicle Ophthalmic Solution	163
Overall Study	NOT COMPLETED	CyclASol Ophthalmic Solution	7
Overall Study	NOT COMPLETED	Vehicle Ophthalmic Solution	3

Source ClinicalTrials.gov

Adverse events16

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	Visual acuity reduced	Eye disorders	CyclASol Ophthalmic Solution	5	162
other	Visual acuity reduced	Eye disorders	Vehicle Ophthalmic Solution	3	166
other	Instillation site pain	Eye disorders	CyclASol Ophthalmic Solution	4	162
other	Instillation site pain	Eye disorders	Vehicle Ophthalmic Solution	2	166
other	Vision blurred	Eye disorders	CyclASol Ophthalmic Solution	2	162
other	Vision blurred	Eye disorders	Vehicle Ophthalmic Solution	4	166
other	Upper respiratory tract infection	Infections and infestations	CyclASol Ophthalmic Solution	8	162
other	Upper respiratory tract infection	Infections and infestations	Vehicle Ophthalmic Solution	7	166
other	Nasopharyngitis	Infections and infestations	CyclASol Ophthalmic Solution	7	162
other	Nasopharyngitis	Infections and infestations	Vehicle Ophthalmic Solution	7	166

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CyclASol Ophthalmic Solution	0	162
Total, all-cause mortality	Vehicle Ophthalmic Solution	0	166
Total, other adverse events	CyclASol Ophthalmic Solution	26	162
Total, other adverse events	Vehicle Ophthalmic Solution	23	166
Total, serious adverse events	CyclASol Ophthalmic Solution	0	162
Total, serious adverse events	Vehicle Ophthalmic Solution	3	166

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34481407	RESULT	PubMed
38334413	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CyclASol Ophthalmic Solution vs Vehicle Ophthalmic Solution: deaths from any cause	Trial comparisons
CyclASol Ophthalmic Solution vs Vehicle Ophthalmic Solution: serious adverse events	Trial comparisons

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/NCT03292809

GET https://conductscience.org/api/trials/v1/NCT03292809/registered

API reference For AI assistants