A Phase 3 interventional study of CyclASol topical ocular, eye drops and Vehicle topical ocular, eye drops in Dry Eye Disease, sponsored by Novaliq GmbH. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Novaliq GmbH · Phase 3, Interventional, and Treatment
Among 11 studies in Dry Eye Syndromes by Novaliq GmbH — none open to participants now, none under way, none of them phase 3. Dry Eye Syndromes · Novaliq GmbH.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, this one is one of 2 that started in 2020, is one of 2 in phase 3, and was the 8th registered.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 834 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →None of the 11 studies in Dry Eye Syndromes by Novaliq GmbH is open now.
Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2020.
Median enrollment 207 across the 7 interventional studies, 33 across the 4 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
Novaliq GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Dry Eye Syndromes by Novaliq GmbH, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cyclosporine A solution in vehicle
Drug: CyclASol topical ocular, eye drops
Vehicle only
Drug: Vehicle topical ocular, eye drops
Cyclosporine A solution in vehicle
Also known as: Ciclosporine (CSA)
Vehicle
Also known as: Vehicle
Change From Baseline in Total Corneal Fluorescein Staining
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
Time frame: baseline and 1 month [day 29]
Change From Baseline in Eye Dryness Score
Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
Time frame: baseline and 1 month [day 29]
Change From Baseline in Total Conjunctival Lissamine Green Staining
Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye.
Time frame: baseline and 1 month [day 29]
Proportion of Responders in Central Corneal Fluorescein Staining Score
≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
Time frame: baseline and 1 month [day 29]
Proportion of Responders in Total Corneal Fluorescein Staining Score
≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst).
Time frame: baseline and 1 month [day 29]
Change From Baseline in Central Corneal Fluorescein Staining
Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
Time frame: baseline and 1 month [day 29]
Change From Baseline in Total Corneal Fluorescein Staining
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
Time frame: baseline and 2 weeks [day 15]
Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision
Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
Time frame: baseline and 1 month [day 29]
| Milestone | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Started | 423 | 411 |
| Completed | 415 | 402 |
| Not completed | 8 | 9 |
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining | -3.96 ± 0.146 | -3.55 ± 0.149 |
Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Eye Dryness Score | -12.2 ± 1.29 | -13.6 ± 1.31 |
Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye.
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Total Conjunctival Lissamine Green Staining | -1.24 ± 0.078 | -0.91 ± 0.079 |
≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
| Participants | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Proportion of Responders in Central Corneal Fluorescein Staining Score | 275 | 238 |
≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst).
| Participants | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Proportion of Responders in Total Corneal Fluorescein Staining Score | 293 | 236 |
Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Central Corneal Fluorescein Staining | -0.79 ± 0.045 | -0.67 ± 0.046 |
Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining | -3.53 ± 0.144 | -2.97 ± 0.147 |
Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision | -7.1 ± 1.19 | -6.1 ± 1.21 |
Collected over Adverse event data was were collected over the study period (29 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CyclASol Ophthalmic Solution | 0/423 (0%) | 2/423 (0.5%) | 45/423 (10.6%) |
| Vehicle Ophthalmic Solution | 0/411 (0%) | 3/411 (0.7%) | 37/411 (9%) |
| Event | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Partial Bowel ObstructionGastrointestinal disorders | 0/423 | 1/411 |
| Herpes Simplex VirusInfections and infestations | 0/423 | 1/411 |
| AppendicitisInfections and infestations | 0/423 | 1/411 |
| Left Foot InfectionInfections and infestations | 1/423 | 0/411 |
| CholelithiasisHepatobiliary disorders | 1/423 | 0/411 |
| Event | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Instillation Site PainGeneral disorders | 45/423 | 37/411 |
| Age, Continuous(years) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 57.6 ± 15.36 | 56.6 ± 16.30 | 57.1 ± 15.83 |
| Sex: Female, Male(Participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Female | 306 | 303 | 609 |
| Male | 117 | 108 | 225 |
| Ethnicity (NIH/OMB)(Participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 62 | 60 | 122 |
| Not Hispanic or Latino | 359 | 348 | 707 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| United States | 423 | 411 | 834 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Sep 2021, 8 months.
Results were first posted in Mar 2023, 1 year 6 months after primary completion.
Of 81 industry-sponsored phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's 8 months is below that.
Counting every sponsor, half of 96 studies reached it within 10 months; a quarter within 7 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Novaliq GmbH