Trial · NCT02280473
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
NCT02280473, Phase 3, Completed, Allergan; results first posted 2017-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease. Trials, record NCT02280473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02280473
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
- NCT number
- NCT02280473
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Dry Eye Syndromes
- Interventions
- Refresh Optive® Gel Drops, REFRESH LIQUIGEL®
- First posted
- 2014-10-31
- Last updated
- 2019-04-16
- Results first posted
- 2017-06-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Baseline, Day 30 | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. |
| Secondary | Change From Baseline in the OSDI© Score | Baseline, Day 7 | The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. |
| Secondary | Change From Baseline in Tear Break-up Time (TBUT) | Baseline, Day 30 | TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient. |
| Secondary | Change From Baseline in the Combined Corneal and Conjunctival Staining Scores | Baseline, Day 30 | The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject. |
| Secondary | Change From Baseline in the Schirmer Test | Baseline, Day 30 | The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject. |
Source ClinicalTrials.gov
Outcomes5
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 the Ocular Surface Disease Index© (OSDI©) Score | Baseline, Day 30 | Intent-to-Treat: All randomized patients | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in the OSDI© Score | Baseline, Day 7 | Intent-to-Treat: All randomized patients | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Tear Break-up Time (TBUT) | Baseline, Day 30 | Intent-to-Treat: All randomized patients | Seconds | MEAN |
| SECONDARY | Change From Baseline in the Combined Corneal and Conjunctival Staining Scores | Baseline, Day 30 | Intent-to-Treat: All randomized patients | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in the Schirmer Test | Baseline, Day 30 | Intent-to-Treat: All randomized patients | mm/5 min | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Refresh Optive® Gel Drops | Baseline | 42.44 | Standard Deviation 11.708 | Scores on a Scale |
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | REFRESH LIQUIGEL® | Baseline | 40.43 | Standard Deviation 11.232 | Scores on a Scale |
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | Refresh Optive® Gel Drops | Change from Baseline at Day 30 | -10.29 | Standard Deviation 15.864 | Scores on a Scale |
| Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score | REFRESH LIQUIGEL® | Change from Baseline at Day 30 | -7.48 | Standard Deviation 16.592 | Scores on a Scale |
| Change From Baseline in the OSDI© Score | Refresh Optive® Gel Drops | Baseline | 42.44 | Standard Deviation 11.708 | Scores on a Scale |
| Change From Baseline in the OSDI© Score | REFRESH LIQUIGEL® | Baseline | 40.43 | Standard Deviation 11.232 | Scores on a Scale |
| Change From Baseline in the OSDI© Score | Refresh Optive® Gel Drops | Change from Baseline at Day 7 | -5.74 | Standard Deviation 14.338 | Scores on a Scale |
| Change From Baseline in the OSDI© Score | REFRESH LIQUIGEL® | Change from Baseline at Day 7 | -2.34 | Standard Deviation 12.294 | Scores on a Scale |
| Change From Baseline in Tear Break-up Time (TBUT) | Refresh Optive® Gel Drops | Baseline | 5.38 | Standard Deviation 1.674 | Seconds |
| Change From Baseline in Tear Break-up Time (TBUT) | REFRESH LIQUIGEL® | Baseline | 5.40 | Standard Deviation 2.138 | Seconds |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Refresh Optive® Gel Drops | 94 | |
| Overall Study | STARTED | REFRESH LIQUIGEL® | 94 | |
| Overall Study | COMPLETED | Refresh Optive® Gel Drops | 93 | |
| Overall Study | COMPLETED | REFRESH LIQUIGEL® | 91 | |
| Overall Study | NOT COMPLETED | Refresh Optive® Gel Drops | 1 | |
| Overall Study | NOT COMPLETED | REFRESH LIQUIGEL® | 3 |
Source ClinicalTrials.gov
Adverse events4
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 | Vision blurred | Eye disorders | Refresh Optive® Gel Drops | 7 | 94 | |
| other | Vision blurred | Eye disorders | REFRESH LIQUIGEL® | 5 | 94 | |
| serious | Hyphaema | Eye disorders | Refresh Optive® Gel Drops | 0 | 94 | |
| serious | Hyphaema | Eye disorders | REFRESH LIQUIGEL® | 1 | 94 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Refresh Optive® Gel Drops | ||
| Total, all-cause mortality | REFRESH LIQUIGEL® | ||
| Total, other adverse events | Refresh Optive® Gel Drops | 7 | 94 |
| Total, other adverse events | REFRESH LIQUIGEL® | 5 | 94 |
| Total, serious adverse events | Refresh Optive® Gel Drops | 0 | 94 |
| Total, serious adverse events | REFRESH LIQUIGEL® | 1 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30573298 | BACKGROUND |
Source 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Refresh Optive® Gel Drops vs REFRESH LIQUIGEL®: serious adverse events |
Source 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/NCT02280473
GET https://conductscience.org/api/trials/v1/NCT02280473/registered