Trial · NCT02974907
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
NCT02974907, Phase 3, Completed, ReGenTree, LLC; results first posted 2022-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2. Trials, record NCT02974907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02974907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
- NCT number
- NCT02974907
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 601 participants, actual
- Lead sponsor
- ReGenTree, LLC
- Conditions
- Dry Eye Syndrome
- Interventions
- RGN-259, Placebo
- First posted
- 2016-11-29
- Last updated
- 2026-10-21
- Results first posted
- 2022-01-05
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Ocular Discomfort | Day 29 | Change from baseline in ocular discomfort change from Pre-Controlled Adverse Environment (CAE) to post-CAE at Day 29 (Visit 5) using the Ora Calibra™ Ocular Discomfort Scale |
| Primary | Change in Fluorescein Staining | Day 29 | Change from baseline in staining at Day 29 pre-CAE in using the Ora Calibra™ scale |
| Secondary | Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE) | Day 8, Day 15, Day 29 | Corneal and conjunctival staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining. |
| Secondary | Fluorescein Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Change From Pre-CAE to Post-CAE, Pre- and Post-CAE) in a Subgroup | Day 8, Day 15, Day 29 | Corneal and conjunctival staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining. |
| Secondary | Lissamine Green Staining (Ora Calibra™ Scale) at Visits 3, 4, and 5 (Pre- and Post-CAE) | Day 8, Day 15, Day 29 | Lissamine green staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining. |
| Secondary | Tear Film Break-Up Time | Day 8, Day 15, Day 29 | Tear film break-up time at Visits 3, 4, and 5 (Pre- and Post-CAE) |
| Secondary | Ocular Protection Index (OPI 2.0) at Visit 5 (Pre-CAE) | Day 29 | Ocular surface drying and tear film stability were measured using the Ora Calibra® OPI 2.0 System. The Ocular Protection Index (OPI) is expressed as the percentage area of tear film breakup and ranges from 0 to 100%, with lower values indicating better ocular surface health. |
| Secondary | Unanesthetized Schirmer's Test at Visit 5 (Pre-CAE) | Day 29 | The Unanesthetized Schirmer's Test measures tear production. A sterile Schirmer test strip was placed in the lower temporal lid margin of each eye, and after 5 minutes, the length of the moistened area on the strip was recorded in millimeters (mm). Higher values indicate greater tear production and a better outcome. |
| Secondary | Drop Comfort Assessment After Randomization at Visit 2 | Day 1 | Drop comfort for each eye was assessed using subject-reported drop comfort scale, which is a 0 to 10 scale and where higher numbers indicating more uncomfortable. |
| Secondary | Ocular Surface Disease Index (OSDI)© at Visits 3, 4, and 5 (Pre-CAE) | Day 8, Day 15, Day 29 | The severity of dry eye disease and its impact on vision-related function were measured using the Ocular Surface Disease Index. Scores range from 0 to 100, with higher scores indicating greater disability. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Discomfort | 29 days after first dosing | score on a scale | MEAN | |
| PRIMARY | Corneal Fluorescein Staining | 29 days after first dosing | score on a scale | MEAN | |
| SECONDARY | Corneal Fluorescein Staining | 8, 15, 29 days after first dosing | |||
| SECONDARY | Unanesthetized Schirmer's Test | 29 days after first dosing | |||
| SECONDARY | Ocular Surface Disease Index (OSDI)© | 8, 15, 29 days after first dosing | |||
| SECONDARY | Tear Film Break-Up Time | 8, 15, 29 days after first dosing | |||
| OTHER_PRE_SPECIFIED | Visual Acuity | 1, 8, 15, 29 days | |||
| OTHER_PRE_SPECIFIED | Change in Biomicroscopy Using the Slit-lamp | 1, 8, 15, 29 days | |||
| OTHER_PRE_SPECIFIED | Adverse Event Query | 1, 8, 15, 29 days | |||
| OTHER_PRE_SPECIFIED | Change in Biomicroscopy Using the Undilated Fundoscopy | 1, 29 days |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Discomfort | RGN-259 | 0.07 | 95% Confidence Interval -0.05 to 0.19 | score on a scale | |
| Ocular Discomfort | Placebo | -0.04 | 95% Confidence Interval -0.15 to 0.08 | score on a scale | |
| Corneal Fluorescein Staining | RGN-259 | 0.07 | 95% Confidence Interval -0.06 to 0.20 | score on a scale | |
| Corneal Fluorescein Staining | Placebo | -0.01 | 95% Confidence Interval -0.13 to 0.12 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RGN-259 | 299 | |
| Overall Study | STARTED | Placebo | 302 | |
| Overall Study | COMPLETED | RGN-259 | 286 | |
| Overall Study | COMPLETED | Placebo | 292 | |
| Overall Study | NOT COMPLETED | RGN-259 | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 10 |
Source ClinicalTrials.gov
Adverse events20
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 | Visual Acuity Reduced | Eye disorders | RGN-259 | 1 | 299 | 1 |
| other | Visual Acuity Reduced | Eye disorders | Placebo | 10 | 302 | 12 |
| other | Eye Pain | Eye disorders | RGN-259 | 3 | 299 | 3 |
| other | Eye Pain | Eye disorders | Placebo | 1 | 302 | 1 |
| other | Nasopharyngitis | Infections and infestations | RGN-259 | 9 | 299 | 9 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 302 | 6 |
| other | Sinusitis | Infections and infestations | RGN-259 | 3 | 299 | 3 |
| other | Sinusitis | Infections and infestations | Placebo | 3 | 302 | 3 |
| other | Upper Respiratory Tract Infection | Infections and infestations | RGN-259 | 3 | 299 | 3 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 1 | 302 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RGN-259 | 0 | 299 |
| Total, all-cause mortality | Placebo | 0 | 302 |
| Total, other adverse events | RGN-259 | 19 | 299 |
| Total, other adverse events | Placebo | 21 | 302 |
| Total, serious adverse events | RGN-259 | 3 | 299 |
| Total, serious adverse events | Placebo | 2 | 302 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RGN-259 vs Placebo: deaths from any cause | Trial comparisons |
| RGN-259 vs Placebo: 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.
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/NCT02974907
GET https://conductscience.org/api/trials/v1/NCT02974907/registered