Keratoconus, UnstablePhase 4NCT04168112
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
A Phase 4 study testing Dextenza and Prednisolone Acetate in people with Keratoconus, Unstable and Collagen Crosslinking, run by Sight Medical Doctors PLLC at 1 site in United States.
Trial summary
There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Unstable, Collagen Crosslinking, Postoperative Pain
- What is being tested?
- Dextenza and Prednisolone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 5 Apr 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive keratoconus with planned corneal cross-linking in one or both eyes
- Age 18 years and older
- Ability to provide informed consent for procedures
- Ability to attend scheduled follow up visits
Who cannot join
- Age less than 18
- Pregnancy/currently breast-feeding
- Inability to provide informed consent
- Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
- Punctal stenosis
- Previous corneal transplant surgery
Show all 12Show fewer
- Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)
- Concurrent use of topical steroid eye drops
- Systemic, topical or intravitreal steroid use within 1 month of baseline
- Active history of chronic or recurrent inflammatory eye disease in either eye
- History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
- History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Trial locations and contacts
1 site in 1 country.
About this study
There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
Read the detailed description
Keratoconus is a progressive ectatic disease of the cornea, leading to worsening of astigmatism and vision over time. With FDA approval of corneal collagen cross-linking (CXL), we now have the ability to halt the progression of keratoconus and prevent further vision loss in these patients. Although CXL has now become standard of care, the immediate post-operative period can be quite painful despite use of anti-inflammatory medications/eye drops. The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye drop therapy.
To date, no studies have been performed evaluating the success of an intracanalicular dexamethasone insert for the treatment of postoperative inflammation and pain in corneal cross-linking patients. Oftentimes, patients experience a great deal of discomfort post-CXL, which may also make it difficult to apply eye drops in the correct fashion. Use of a dexamethasone insert alleviates the need for postoperative steroid eye drops and may provide increased pain relief post-CXL as compared to topical therapy. This will be a head-to-head study where steroid therapy (topical or insert) will begin in a standard fashion on the date of CXL. This will allow for accurate comparison of a 4-week taper of topical steroids, versus a dexamethasone insert designed to release steroid for 30 days.
- Being tested
- Dextenza, Prednisolone Acetate
- Keywords
- Collagen Crosslinking, Keratoconus, Dexamethasone, Intracanalicular Insert
- Medical subject headings
- Keratoconus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextenzaDrug
Also called Intracanalicular dexamethasone insert
Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
Prednisolone AcetateDrug
post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days). Receives: Drug: Dextenza |
| Group B | Active comparator | Patients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week. Receives: Drug: Prednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Measured: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Assessment of corneal edema/cells (if any), degree of conjunctiva injection (if any) Grading will be from 0 to 4, with "0" being no conjunctival injection, and "4" indicating severe, diffuse conjunctival injection. Presence of corneal cells will be noted if present or absent.
Measured: assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Secondary outcomes (3)
Rate of Corneal Re-epithelialization
Evaluation of rate of corneal re-epithelialization post-crosslinking at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4
Measured: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Questionnaire at final visit regarding ease of postoperative eye drop use
Measured: postoperative week 4 (POW4)
Notation of Need for Use of "Rescue" Pain Medication
Use of oral non-steroidal anti-inflammatory (NSAID), acetaminophen, prescribed pain medication) between groups
Measured: Assessement of use of additional/adjunctive pain/antiinflammatory medications will be done for each patient at postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start12 Feb 2020
- Primary completion24 Oct 2022
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Keratoconus, UnstableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two cohorts of patients will be studied (10 patients each group). Cohort A: intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or another class if allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily x 10 days). Cohort B: Patients are placed on standard postoperative regimen of postoperative fluoroquinolone antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily (QID) x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: 4 times daily x1 week, three times daily (TID) x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Medical Doctors PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Alanna Nattis, DO, Sight Medical Doctors PLLC
- Investigators
- Alanna Nattis, DO, Principal investigator, Sight Medical Doctors PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168112
- Sponsor's protocol ID
- LINK1
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2019
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) with other researchers. However, any adverse events will be reported to the governing institutional review board (IRB) and Ocular Therapeutix and FDA if applicable.
Publications
Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
PubMed 9493273Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. doi: 10.1016/0039-6257(84)90094-8.
PubMed 6230745Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
PubMed 12719068Kohlhaas M, Spoerl E, Schilde T, Unger G, Wittig C, Pillunat LE. Biomechanical evidence of the distribution of cross-links in corneas treated with riboflavin and ultraviolet A light. J Cataract Refract Surg. 2006 Feb;32(2):279-83. doi: 10.1016/j.jcrs.2005.12.092.
PubMed 16565005Hoyer A, Raiskup-Wolf F, Sporl E, Pillunat LE. [Collagen cross-linking with riboflavin and UVA light in keratoconus. Results from Dresden]. Ophthalmologe. 2009 Feb;106(2):133-40. doi: 10.1007/s00347-008-1783-2. German.
PubMed 18604541Wollensak G, Sporl E, Seiler T. [Treatment of keratoconus by collagen cross linking]. Ophthalmologe. 2003 Jan;100(1):44-9. doi: 10.1007/s00347-002-0700-3. German.
PubMed 12557025Snibson GR. Collagen cross-linking: a new treatment paradigm in corneal disease - a review. Clin Exp Ophthalmol. 2010 Mar;38(2):141-53. doi: 10.1111/j.1442-9071.2010.02228.x.
PubMed 20398104Peyman A, Kamali A, Khushabi M, Nasrollahi K, Kargar N, Taghaodi M, Razmjoo H, Fazel F, Salesi A. Collagen cross-linking effect on progressive keratoconus in patients younger than 18 years of age: A clinical trial. Adv Biomed Res. 2015 Nov 23;4:245. doi: 10.4103/2277-9175.170240. eCollection 2015.
PubMed 26693470Ghanem VC, Ghanem RC, de Oliveira R. Postoperative pain after corneal collagen cross-linking. Cornea. 2013 Jan;32(1):20-4. doi: 10.1097/ICO.0b013e31824d6fe3.
PubMed 22547128Zarei-Ghanavati S, Jafarpour S, Radyn-Majd A, Hosseinikhah-Manshadi H. Evaluation of early postoperative ocular pain after photorefractive keratectomy and corneal crosslinking. J Cataract Refract Surg. 2018 May;44(5):566-570. doi: 10.1016/j.jcrs.2018.02.019. Epub 2018 May 9.
PubMed 29753555Serna-Ojeda JC, Santana-Cruz O, Quiroz-Casian N, Gonzalez-Mendoza E, Mercado-Orozco JL, Navas A, Lichtinger A, Graue-Hernandez EO. Pain Management in Corneal Collagen Crosslinking for Keratoconus: A Comparative Case Series. J Ocul Pharmacol Ther. 2019 Jul/Aug;35(6):325-330. doi: 10.1089/jop.2019.0021. Epub 2019 Jun 19.
PubMed 31216215Kocluk Y, Cetinkaya S, Sukgen EA, Gunay M, Mete A. Comparing the effects of two different contact lenses on corneal re-epithelialization after corneal collagen cross-linking. Pak J Med Sci. 2017 May-Jun;33(3):680-685. doi: 10.12669/pjms.333.12241.
PubMed 28811794Nattis AS, Rosenberg ED, Rasool F. Intracanalicular dexamethasone insert for post-corneal crosslinking inflammation and pain: the LINK study. J Cataract Refract Surg. 2023 Nov 1;49(11):1114-1119. doi: 10.1097/j.jcrs.0000000000001279.
PubMed 37532250
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
- ClinicalTrials.gov ID
- NCT04168112
- Acronym / sponsor ID
- LINK1
- Keywords
- Collagen Crosslinking, Keratoconus, Dexamethasone, Intracanalicular Insert
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sight Medical Doctors PLLCUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
Detailed description
Keratoconus is a progressive ectatic disease of the cornea, leading to worsening of astigmatism and vision over time. With FDA approval of corneal collagen cross-linking (CXL), we now have the ability to halt the progression of keratoconus and prevent further vision loss in these patients. Although CXL has now become standard of care, the immediate post-operative period can be quite painful despite use of anti-inflammatory medications/eye drops. The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye drop therapy.
To date, no studies have been performed evaluating the success of an intracanalicular dexamethasone insert for the treatment of postoperative inflammation and pain in corneal cross-linking patients. Oftentimes, patients experience a great deal of discomfort post-CXL, which may also make it difficult to apply eye drops in the correct fashion. Use of a dexamethasone insert alleviates the need for postoperative steroid eye drops and may provide increased pain relief post-CXL as compared to topical therapy. This will be a head-to-head study where steroid therapy (topical or insert) will begin in a standard fashion on the date of CXL. This will allow for accurate comparison of a 4-week taper of topical steroids, versus a dexamethasone insert designed to release steroid for 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohorts of patients will be studied (10 patients each group). Cohort A: intracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or another class if allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily x 10 days). Cohort B: Patients are placed on standard postoperative regimen of postoperative fluoroquinolone antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye 4 times daily (QID) x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: 4 times daily x1 week, three times daily (TID) x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: DextenzaIntracanalicular dexamethasone insert is placed on day of crosslinking (CXL); patients will still receive postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days). |
| Group B | Active comparator | Drug: Prednisolone AcetatePatients are placed on standard postoperative regimen of postoperative fluoroquinolone (or other class in case of allergy) antibiotic eye drops with instructions for use (i.e. 1 drop in operative eye QID x 10 days) and Prednisolone acetate 1% ophthalmic solution tapered over 1 month in the following schedule: QID x1 week, TID x 1 week, BID x 1 week, and Qday x 1 week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Progressive keratoconus with planned corneal cross-linking in one or both eyes
- Age 18 years and older
- Ability to provide informed consent for procedures
- Ability to attend scheduled follow up visits
Key exclusion criteria (12 listed)
- Age less than 18
- Pregnancy/currently breast-feeding
- Inability to provide informed consent
- Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
- Punctal stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextenzaAlso: Intracanalicular dexamethasone insertPlacement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain | Drug | Group A |
| Prednisolone Acetatepost-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month | Drug | Group B |
Primary outcome
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Time frame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4)
Time frame: assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Assessment of corneal edema/cells (if any), degree of conjunctiva injection (if any) Grading will be from 0 to 4, with "0" being no conjunctival injection, and "4" indicating severe, diffuse conjunctival injection. Presence of corneal cells will be noted if present or absent.
3 secondary outcomes
Rate of Corneal Re-epithelialization
Time frame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert
Time frame: postoperative week 4 (POW4)
Notation of Need for Use of "Rescue" Pain Medication
Time frame: Assessement of use of additional/adjunctive pain/antiinflammatory medications will be done for each patient at postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9493273Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
- Background: PubMed 6230745Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. doi: 10.1016/0039-6257(84)90094-8.
- Background: PubMed 12719068Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
- Background: PubMed 16565005Kohlhaas M, Spoerl E, Schilde T, Unger G, Wittig C, Pillunat LE. Biomechanical evidence of the distribution of cross-links in corneas treated with riboflavin and ultraviolet A light. J Cataract Refract Surg. 2006 Feb;32(2):279-83. doi: 10.1016/j.jcrs.2005.12.092.
- Background: PubMed 18604541Hoyer A, Raiskup-Wolf F, Sporl E, Pillunat LE. [Collagen cross-linking with riboflavin and UVA light in keratoconus. Results from Dresden]. Ophthalmologe. 2009 Feb;106(2):133-40. doi: 10.1007/s00347-008-1783-2. German.
- Background: PubMed 12557025Wollensak G, Sporl E, Seiler T. [Treatment of keratoconus by collagen cross linking]. Ophthalmologe. 2003 Jan;100(1):44-9. doi: 10.1007/s00347-002-0700-3. German.
- Background: PubMed 20398104Snibson GR. Collagen cross-linking: a new treatment paradigm in corneal disease - a review. Clin Exp Ophthalmol. 2010 Mar;38(2):141-53. doi: 10.1111/j.1442-9071.2010.02228.x.
- Background: PubMed 26693470Peyman A, Kamali A, Khushabi M, Nasrollahi K, Kargar N, Taghaodi M, Razmjoo H, Fazel F, Salesi A. Collagen cross-linking effect on progressive keratoconus in patients younger than 18 years of age: A clinical trial. Adv Biomed Res. 2015 Nov 23;4:245. doi: 10.4103/2277-9175.170240. eCollection 2015.
- Background: PubMed 22547128Ghanem VC, Ghanem RC, de Oliveira R. Postoperative pain after corneal collagen cross-linking. Cornea. 2013 Jan;32(1):20-4. doi: 10.1097/ICO.0b013e31824d6fe3.
- Background: PubMed 29753555Zarei-Ghanavati S, Jafarpour S, Radyn-Majd A, Hosseinikhah-Manshadi H. Evaluation of early postoperative ocular pain after photorefractive keratectomy and corneal crosslinking. J Cataract Refract Surg. 2018 May;44(5):566-570. doi: 10.1016/j.jcrs.2018.02.019. Epub 2018 May 9.
- Background: PubMed 31216215Serna-Ojeda JC, Santana-Cruz O, Quiroz-Casian N, Gonzalez-Mendoza E, Mercado-Orozco JL, Navas A, Lichtinger A, Graue-Hernandez EO. Pain Management in Corneal Collagen Crosslinking for Keratoconus: A Comparative Case Series. J Ocul Pharmacol Ther. 2019 Jul/Aug;35(6):325-330. doi: 10.1089/jop.2019.0021. Epub 2019 Jun 19.
- Background: PubMed 28811794Kocluk Y, Cetinkaya S, Sukgen EA, Gunay M, Mete A. Comparing the effects of two different contact lenses on corneal re-epithelialization after corneal collagen cross-linking. Pak J Med Sci. 2017 May-Jun;33(3):680-685. doi: 10.12669/pjms.333.12241.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) with other researchers. However, any adverse events will be reported to the governing institutional review board (IRB) and Ocular Therapeutix and FDA if applicable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alanna Nattis, DO principal investigator
Sight Medical Doctors PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza and Prednisolone Acetate in people with Keratoconus, Unstable and Collagen Crosslinking, run by Sight Medical Doctors PLLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4) (time frame: Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168112, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.