A Phase 2/3 interventional study of CyclASol topical ocular, eye drops and Vehicle topical ocular, eye drops in Dry Eye Disease, sponsored by Novaliq GmbH. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Novaliq GmbH · Phase 2/3, Interventional, and Treatment
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.
Exclusion Criteria:
Cylclosporine 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 at 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.
Time frame: baseline and 1 month [day 29]
Change From Baseline in Ocular Surface Disease Index at 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.
Time frame: baseline and 1 month [day 29]
| Milestone | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Started | 162 | 166 |
| Completed | 155 | 163 |
| Not completed | 7 | 3 |
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.
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining at Day 29 | -2.9 ± 2.59 | -2.2 ± 2.73 |
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.
| score on a scale | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index at Day 29 | -7.08 ± 18.650 | -5.37 ± 15.291 |
Collected over 85 Days ± 2 (Randomization until Study Exit). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CyclASol Ophthalmic Solution | 0/162 (0%) | 0/162 (0%) | 26/162 (16%) |
| Vehicle Ophthalmic Solution | 0/166 (0%) | 3/166 (1.8%) | 23/166 (13.9%) |
| Event | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 0/162 | 1/166 |
| PneumoniaInfections and infestations | 0/162 | 1/166 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 0/162 | 1/166 |
| Event | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 8/162 | 7/166 |
| NasopharyngitisInfections and infestations | 7/162 | 7/166 |
| Visual acuity reducedEye disorders | 5/162 | 3/166 |
| Instillation site painEye disorders | 4/162 | 2/166 |
| Vision blurredEye disorders | 2/162 | 4/166 |
| Age, Continuous(years) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 61.5 ± 13.6 | 61.3 ± 12.66 | 61.4 ± 13.11 |
| Sex: Female, Male(Participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Female | 116 | 119 | 235 |
| Male | 46 | 47 | 93 |
| Ethnicity (NIH/OMB)(Participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 11 | 26 |
| Not Hispanic or Latino | 147 | 155 | 302 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 14 | 19 | 33 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 16 | 14 | 30 |
| White | 130 | 127 | 257 |
| More than one race | 0 | 3 | 3 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | CyclASol Ophthalmic Solution | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| United States | 162 | 166 | 328 |
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Novaliq GmbH