Trial · NCT04225611
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
NCT04225611, Phase 1, Phase 2, Recruiting, Massachusetts Eye and Ear Infirmary
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema. Trials, record NCT04225611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225611
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
- NCT number
- NCT04225611
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, estimated
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Cystoid Macular Edema
- Interventions
- Dexamethasone
- First posted
- 2020-01-13
- Last updated
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Contact Lens Related Ocular Infection | 28 Days | Number of ocular infection incidents for the duration of the study |
| Primary | Occurrence of Corneal epithelial Defect | 28 Days | Number of corneal epithelial defects incidents for the duration of the study |
| Primary | Occurrence of ocular hypertension greater than 28 | 28 Days | Number of ocular hypertension incidents for the duration of the study (ocular hypertension greater than 28) |
| Secondary | OCT Macular Thickness Change | 28 Days | Changes in ocular coherence tomography (OCT) macular thickness over the duration of the study |
| Secondary | Percentage of subject that achieve OCT Macular Thickness Decrease of 50 μm | 28 Days | Percentage of subjects that achieve a 50 μm decrease in OCT macular thickness from baseline to study completion |
| Secondary | Changes is Visual Acuity | 28 Days | Change in vision (letter gain with and without pinhole vision) from baseline to the end of the study. |
| Secondary | Percentages of subjects with 15 letter gain | 28 Days | Percentage of subjects that achieve a 15 letter gain from baseline to the end of the study |
| Secondary | Percentage of subjects that require rescue Medication | Day 21 | Percentage of subjects that require rescue medication at day 21 |
| Other | Changes in Modified Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) | 28 Days | Change in subjects survey scores over time. Total score range between 1 - 28. Lower CLDEQ score means subject are experiencing high comfort. High CLDEQ score means higher discomfort. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04225611
GET https://conductscience.org/api/trials/v1/NCT04225611/registered